The key to good end-user training for eQuality Management Systems

The key to good end-user training for eQuality Management Systems

At the end of a QMS implementation project

The only important question is how well the users accept and use the system. You may have done the project perfectly: staying on-time, in-budget, with high quality; but in the end, none of these matter if the users are not using the system.

Who hasn’t experienced this scenario? A challenging and time-consuming project is finally finished! The new application has been implemented to support the team’s daily work and improve efficiency. Maybe new processes were designed that are changing the way things are done. For sure the team needs to learn to work with the new tool.

“New” means something unknown.

“New” does not mean better.

For the new application a small group of people have been involved in the requirements gathering and testing. They have done their best to properly represent their colleagues or functions. They have tried to think of all the scenarios that need to be covered by the new application. They are very proud of all the effort they have put into this. But in the end, the new application will be used by a much wider group of people who might not be as enthusiastic about it but will have to use it nonetheless.

So how can you get these people on board? The first step, as in many other cases, is good change management and communication throughout the project. The project team should maintain an open-door approach, continuously sending out brief, yet informative communications about the progress of the project. The goal here is to get everyone interested from the beginning and maintain their interest by keeping them up-to-date.

Don’t make the new software a surprise

An important decision in the implementation project is the training approach and creation of the training material:

    • How should the material be structured?
    • What is the best way to conduct the training?
    • Would it make sense to follow a train-the-trainer approach?
    • Will everyone be trained together, or does it make more sense to split them into groups?

We all know we have special challenges during these times, and it might not be possible to get everyone in one training room (which is usually the preferable approach). So, what are the options? Are there best practices for organizing these trainings?

I’m happy to share some insights and experiences that we have collected over the last few years with different customers.

In many cases, the time and effort required for creating good training material is underestimated. Projects are under time constraints, sometimes delayed – and then you are supposed to think about the correct training approach and spend days or weeks to develop high-quality, effective training material?

The answer is yes – you should think of the right approach and yes – you should definitely invest enough time for the creation of the training material. It is worth it! All the time and money you are spending for the project will be wasted if the application is not adopted and properly used by the business users.

The first impression counts

You only have one chance to win over the business users and get them to use the system, so make the first impression count. The training should be a mix of an overall system overview plus special topics based on daily activities of the users. In many cases, it makes sense to split up the training by roles. It is always a good approach to provide an overall overview first and then focus on the role-specific details.

Typically, you will have different types of personalities to accommodate, but you know your team members inside out. Identify the reluctant candidates early on and make a concerted effort to get them excited about and invested in the new system. Some of the potential detractors can be turned around to become promoters of the new system. It is normal for people to be reluctant to change; that’s part of human nature as change can be a difficult process to handle. Always keep this in mind.

Take all concerns seriously and implement a change management process

Include someone from management or the project sponsor at the beginning of the training. This person should explain the motivation behind the project, discuss the importance, and identify the improvements that will be realized once the application is implemented. All attendees will be part of something important. The worst scenario that could happen is where the users refuse to use the system. It must be a priority to prevent this from happening. But what can you do?

Involve these people. Make them feel important. Even if not needed, create a title for them such as “Local Business Advisor for….”, “Super …. User” or “Local Admin”. Don’t focus on the people who are already convinced, instead choose the people who are not. You might think is this crazy! Why should I do this? Because this is the key to success! If you can get the reluctant users to support and promote the new application, you are well-positioned for a successful start and it is likely that the positive spirit will continue after go-live.

Make sure you explain not only the technical functions of the system but also why it needs to be used in the defined way. There were reasons why it was designed like this; make these reasons transparent. Ask for any questions or concerns and offer a way to collect feedback. Everyone has a responsibility to help improve the system, so give everyone the opportunity to share their thoughts. Make sure to emphasize that feedback is very welcome and important. No system is 100% perfect. Implement a change management process to make sure you not only collect but also review and evaluate the feedback. Keep the requestors in the loop about what is happening with their requests.

Even if you provide excellent training, the users will not be able to remember everything that was covered during the training session. To support the users after the training session, be sure to provide high-quality training materials. These materials should be easy to understand and simple to follow. When creating the training materials, consider any obstacles users may face and include guidance to ensure these obstacles are easily overcome by the user. Good training material should be a mix of step-by-step instructions on how to use the system and explanations to help the user select the correct values or enter the correct type of data.

Training, tools, and tenacity

In the end, the regular use of the system will automatically improve the competence and confidence of the users. But in the beginning, providing users with training, tools, and tenacity will promote long-term data quality. We hope the insights and ideas provided can help you generate and conduct successful training for your users.

Please reach out to us to discuss your specific challenges. Our team of consultants will be happy to connect with you in a free assessment call to learn about your individual situation and to lay out for you how fme can support you on your path to a successful and effective training execution.

About the author

Alicia Whitney has been working with compliant, validated computer systems since 2010 when she started her career at a small pharmaceutical company in Pennsylvania, USA. Collaboratively implementing and validating document management, quality management, and inventory management systems, she has gained knowledge and experience in many areas of the pharmaceutical industry. Since joining fme Life Sciences in 2018, Ms. Whitney has continued to provide an experienced perspective when gathering requirements and guiding assessments for client implementations. Ms. Whitney continues to build on her experience, now holding certifications on TrackWise Digital QMS and VeevaVault Platform.

fme Life Sciences is a leading provider of business and technology services supporting the deployment of Content Services and ECM solutions to its clients in the Life Sciences Industry. We act as a trusted advisor and systems integration specialist across the Clinical, Regulatory and Quality and Manufacturing domains in Europe and North America. We do not exclusively recommend or promote any platform or vendor, but rather we focus on providing our clients with an independent perspective of the solutions available in the market.

Key Factors when selecting an electronic Quality Management System

Key Factors when selecting an electronic Quality Management System

1. Compliance

How does the proposed solution work within the scope of 21 CFR Part 11 and/or Annex 11?

Any electronic Quality Management System (eQMS) that is marketed for the Pharmaceutical industry will have built-in functionality to meet the requirements needed for compliance. However, if the solution is not designed for pharmaceutical companies, the question of compliance should be raised early in the selection process. An evaluation must be completed to ensure a compliant approach will be achievable and to determine whether it is sensible within the cost and time constraints of the planned implementation project.

If the Quality Management Systems that you’re considering are scoped for pharmaceutical industry, be sure to think about the validation cycles required for hosted or SaaS model solutions. Will your users be available for testing? Will the business be accepting of outages and down time to support regular deployments of new configurations? Who will be responsible to analyze and accept the defined risk for upcoming changes?

For any eQMS implemented for your business, the question of upgrades will regularly arise. Those solutions on the hybrid cloud or SaaS model will prompt a more urgent response to the question of validation as there are vendor release cycles to observe. The business will need a dynamic, responsive risk-based analysis and assessment of changes and quick turnaround of the validation/verification actions to maintain the validated status of the system. This is certainly not an impossible task as so many businesses use SaaS solutions, but it is an important area to evaluate and plan for when deciding which solution to choose.

2. Scope

What information and data does the business need the eQMS to manage? The various solutions offered can accommodate some, or all, Quality Management areas for the business. In most cases, the business can decide the extent of those areas that will be managed within the eQMS. Consider whether all existing Quality solutions should be incorporated into a single solution, or if the new system should start small and expand to other areas over time. Look to identify the processes with the largest pains in place currently; a clue for identifying those processes is to look for the overall time it takes for the records to close. Industry standards for Change Control, Deviation, and Audits will provide a benchmark for how well you are keeping to the schedule. If these quality management actions are regularly falling outside of these benchmarks, it could signal that the process needs some improvements, and those improvements can often be realized by implementing an electronic system for managing the events.

The ability to manage supplier quality is also something that many of the solutions offer. Either through an oversight process or by allowing the supplier to log on to your solution to create quality-related records – this functionality can help to alleviate some time-consuming processes in the business working with suppliers.

Another scope related question is that of the platform’s ability to support business areas that fall outside of the immediate quality-related focus. For example, Supplier Audits can often signal the health of the relationship with that supplier. Regularly failing a supplier during an audit can alert the contracting department, prompting updates to existing contracts or even termination of a contract, or suggesting qualification of an alternate supplier. Similarly, managing status changes for releasing batches of products can be automated to ensure that unreleased products or products requiring investigations remain on hold status.

Identify the departments and sites that will be involved in the process to implement, and most of all, in the use the future eQMS. The application might only apply to some sites depending on the actions taken at those sites, so it is better to avoid opening up too many new topics while you are just starting out. Also be sure to include stakeholders from the beginning so that they won’t be surprised with the finished product. Last minute updates to their processes or their migration activities can be a disaster.

3. Transferability

What is the approach for transferring existing eQMS data and information? Consider that once you select an eQMS and are ready to start the implementation process – the ability to bring your existing data and records into the new system might be another decision point. There is always a way to accomplish this type of migration, it is a question of whether or not there is sufficient value after go-live. Some considerations include whether the system can easily accommodate existing records: is there enough metadata to support the base requirements in the future eQMS or will additional enrichment or system configuration changes be necessary to support importing this information?

In the event a new site is added to your company, how will the eQMS adapt to new processes, users, and data? Implementing a system to meet known requirements can be attainable, however if the system is not scalable or flexible to accommodate future business, you might end up in a place where you will need to select a new eQMS and repeat the process once again.

Also, what happens when you add a new product to or divest a product from your portfolio? Will it be straightforward to update the eQMS? Or will you need to allocate time and material to the efforts? How will this change affect the validated status of your eQMS? Just to list a few of the considerations.

4. Maintenance/Upgrade paths

When implementing any software solution, it is important to assign and spread responsibilities to make sure that none of your team members will be overloaded. Consider where the responsibility would lie for the software maintenance. Who will solve infrastructure issues? Who will maintain user access and group membership? Who will plan and implement the upgrades? What impact will upgrades and maintenance have on the business? What effect will the upgrades have on your end users? Who will train the users on new functionality? Who will decide which functionality to turn on or validate?

5. Cost

Last but not least, of course one of the top considerations for your financial team will be the cost of the solution. Even in this area there are multiple options to consider, the most obvious difference is a one-time license (with annual support engagement costs) versus a subscription model. Both models have benefits and drawbacks, so consider the following questions when evaluating:

  • One-time License payment
    – Are the user counts consistent?
    – Does the business have resources available to support the infrastructure?
    – Will the business users be satisfied with a less agile solution and patient for upgrades/improvements
  • Subscription model:
    – Will the validation resources be available to maintain the validated system status?
    – Does the business prefer a more dynamic solution with new features released regularly?
    – Does the business support training users on new functionality with the software releases?

There are quite a few factors to consider when selecting the most fitting eQMS for your business. Evaluating the benefits, risks, and on-going maintenance requirements for the available solutions is not an easy task. But defining the different considerations and evaluating the options available against a uniform set of criteria, can help your team to select the best fitted solution to enable your business to manage patient safety and product quality with a successful outcome all around.

About the author

Alicia Whitney has been working with compliant, validated computer systems since 2010 when she started her career at a small pharmaceutical company in Pennsylvania, USA. Collaboratively implementing and validating document management, quality management, and inventory management systems, she has gained knowledge and experience in many areas of the pharmaceutical industry. Since joining fme Life Sciences in 2018, Ms. Whitney has continued to provide an experienced perspective when gathering requirements and guiding assessments for client implementations. Ms. Whitney continues to build on her experience, now holding certifications on TrackWise Digital QMS and VeevaVault Platform.

fme Life Sciences is a leading provider of business and technology services supporting the deployment of Content Services and ECM solutions to its clients in the Life Sciences Industry. We act as a trusted advisor and systems integration specialist across the Clinical, Regulatory and Quality and Manufacturing domains in Europe and North America. We do not exclusively recommend or promote any platform or vendor, but rather we focus on providing our clients with an independent perspective of the solutions available in the market.
“Data Discernment – A simplified approach to strategic study and portfolio planning.”

“Data Discernment – A simplified approach to strategic study and portfolio planning.”

Now, with the rapid innovation in eClinical system technology, a Sponsor can more readily find a CTMS solution that supports exactly their business profile – enhancing strategic insights without unnecessarily encumbering the clinical operations process.

Most small-to-midsize clients focus on two key areas when using CTMS to enhance data accessibility

1. Enrollment Metrics
Key Areas of Concern – patient recruitment and screen failure rate, open to enrollment to first patient enrolled, patients enrolled and not completing all visits (breakdown analytics for interim visits, safety events, and/or protocol deviations), target enrollment, accrual timeline.

2. Site Performance
Key Areas of Concern – study start-up timelines/spend, protocol compliance and deviations, safety reporting, data entry timeliness and accuracy, clinical document quality.

These two areas provide the greatest/earliest indication of protocol success or on-going risk, as well as return on study investment. And, so the question becomes, should the Sponsor bring the necessary data points in-house using CTMS as a nexus for cross-functional collaboration? Great question.

Use skills, experience, and resources of your CRO to your greatest advantage!

Essentially, CROs have a deeper data lake and access to more robust, well-rounded data points. It’s a volume game, pure and simple. Unless your organization has very specific goals in mind, it likely isn’t worth the cost and resourcesto duplicate the data collection efforts, particularly if the CRO has been contracted to perform a majority of the study activities.
Another important consideration is application maintenance. When the CTMS application is cloud-based and subject to periodic release updates – like Veeva Vault Clinical – any integration must be tested and maintained to ensure integrity of both the connection and the data communicated thereby. This can be a big resourcing effort, considering the 3x Annual Veeva Vault Release schedule.

Get specific and targeted with meaningful KPIs

When Sponsor goals dictate that it is time to bring data in-house (worth the implementation and maintenance efforts), be highly targeted. Choose specific, meaningful Sponsor-priority KPIs to capture in the CTMS environment, then leverage Vault application features to boost efficency in on-going management activities. Resist the urge to capture data simply because there is a visible field available or an out-of-the-box report associated with it; if you don’t need it, hide it.

Recap

In this blog series, we discussed the importance of a simplified eClinical system environment, then juxtaposed compliance „have-to-dos“ with strategic „want-to-dos“ using a simple framework, and voila – a hybrid governance:maturity map. Using this map, you’re ready to drive innovation both internally and within the industry. And, if you need some extra help, just ask – fme is here to support you!

About the author

Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.

DIA Conference Summary ’21

DIA Conference Summary ’21

Administered in virtual format, the content offered was in great depth and actually more easily accessible than when attending in-person – no need to find the right conference space or meeting room, just click into the right virtual space and engage immediately! Granted, the social and networking aspect is certainly challenging and the overarching experience – bright lights, high energy, places to go and discussions to attend – wasn’t the normal, but it was a solid „new normal“ for 2021’s sake.

The Clinical Operations track offered was focused on (1) immediate impact of the COVID-19 pandemic on clinical trials, (2) lessons learned from pivoting and working hard to „keep the lights on“ in research over the past 18 months, and (3) lasting innovations stemming from work done during this time.

Here is just a quick tour of key presentations that drive home the theme of technological innovation in the name of patient-centric enablement in clinical trials:

Patients: „Technology-Driven Endpoints for Patient Retention“

This was an excellent presentation addressing trends in clinical trial approach related to study design, decentralized solutions, patient centricity, and increased analytics related to risk managment and trial KPIs, in general. The team spoke to current and future necessity of eConsent, TeleMedicine, eCOA, and a broad range of connectivity inherent to data capture, analysis, and operationalization in this space. The moral of the story is that we’ve only just brushed the surface of what the technological landscape can support in drug, device, and biomedical innovation; doing this responsibly and with agility is the challenge for the future.

Operations: „Technology Changes Needed to Manage Drug Supply for Decentralized Trials“

Agile logistics and decentralized trials, in general, are huge topic areas in the post-COVID life sciences landscape. Here, decentralization was addressed from a patient-centric approach as relates to access and cost efficiency. The presentation team stressed agility in supply chain strategy (i.e. Personalized Distribution, Central Depot to Site, Regional Country Depot to Affiliate) in conjunction with global process support (from SOPs to cross-collaborative SMEs) as the key factors in effective decentralization.

Regulators: „Reliability of Data: What Does It Mean and How Can It Be Accomplished“

When the FDA comes to the table with data quality guidance, it’s a good opportunity to listen! The big message to Sponsors: „Pay attention to what the data is telling you over the course of the study and do something about it.“ The FDA presentors emphasized a shift in thinking, urging Sponsors to to embrace an active data analytical approach related to patient safety and data integrity. Essentially, with the greater availability of technology to support innovation, the expectation is that Sponsors embrace what is available to more quickly, efficiently, and effectively bring drugs/devices to market; With this comes a greater responsibility to ensure (and sustantiate) due diligence at every step along the way.

Overall, the message from the DIA Annual Conference was clear – technology is here, it helped us do great things during a global crisis. Now, let’s take this momentum and put it to even better use into the future. A nobel and exciting call to action!

About the author

Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.

Why Do You Need an Electronic Quality Management System (eQMS)?

Why Do You Need an Electronic Quality Management System (eQMS)?

1. Increase the quality of your processes while saving time and working remotely if needed

“Paper processes have always worked fine for us…” is a common objection when it comes to discuss introducing an eQMS. Yes, paper is an improvement over previous tracking methods: memory, stone tablet, bamboo. However computers can be trusted as well , and are quite a bit better than these tracking methods. Plus, there are additional capabilities that an electronic system provides. For example, the eQMS can include validation checks to improve the proportion of right-first-time entries, requiring fewer revisions and eradicating errors commonly encountered with paper processes.

One of the most valid reasons to move away from paper processes surfaced in the recent, sudden need to shift to remote work. Some work must be completed on-site (such as any true manufacturing related tasks), however supporting actions for these tasks may be handled remotely. Implementing an eQMS can support these tasks in a more streamlined, compliant, and user-friendly manner than any of the ad hoc solutions that likely had to be brought in place in short order to support the recent in-office interruption.

Finally, eQMS solutions can also save time for the end users; pre-populated picklists, system-calculated dates, and the ability to clone existing records, are all basic out-of-the-box actions in the typical eQMS. Once implemented, the eQMS will free up your users to think about the actual work that humans are required to complete, like the five-whys of any quality event. Instead of issuing tracking numbers for each event, all of the eQMS solutions are able to assign unique IDs to records right when they are created. Manually managing Change Control numbers with a logbook will be an easily forgotten memory.

“If you didn’t document it, it didn’t happen.” How often have we heard that mantra? Electronic systems have benefits of requiring users to enter certain information or select pre-defined values for a field. Combined with the standard audit trail functionality included in the eQMS solutions, traceability for any action logged within the eQMS is a snap.

2. Guaranteed security, back-up and availability of your business critical data

“Storage of paper records is not a problem…” is what I often hear my clients say. Paper records need to be retained for years past the expiration date of batches produced, and need to be held on-site or at a storage supplier who needs to be qualified, paid, and regularly audited. Even when the most careful approach is taken, incidents still can occur and there is no path to regaining those original documents.

Some businesses rely on SharePoint or file directory storage for maintaining documentation instead of paper records. Certainly this is an improvement over the physical paper copy, however managing access to the different SharePoint locations and the unmitigated disorganization of end users creating their own folder structure or guessing where a document should be stored can create a nightmare scenario for upgrades, re-organizations, or the divestiture or acquisition of specific areas in the business.

eQMS Systems provide a level of confidence in the ability to maintain themselves without the need of an additional disaster-proof location. Server rooms are already part of the standard disaster recovery plans and backups are taken regularly to ensure business continuity. Alternatively, the leading providers of eQMS Systems for the Life Sciences industry all offer hosted options for your environment, with insurances and assurances that your data will be secure, backed-up, and available to you whenever you need access.

3. Accelerate Annual Product Reviews (APR) or Product Quality Reviews (PQR)

“Tracking, Trending, and reporting using paper records is well-managed in a spreadsheet…” – another frequent misconception in this context. Preparing Annual Product Review (APRs) or Product Quality Review (PQR) with a paper eQMS is time consuming. Gathering real-time data to support business decisions can be challenging.

Reporting has never been easier using an eQMS. One-click reporting solutions that are highly configurable and easy to set up by business administrators can cut through the data to help you know where the holdup is in your processes. Systems also provide the option to send automated emails to the interested parties, which can even be sent to external partners helping with supplier management and transparency of identifiying existing or potential issues.

Trending is also easier in an electronic system. Rules can be set up to notify specific users/groups or even take actions on behalf of a human, like opening an Investigation for multiple Out of Specification (OOS ) events logged for a specific lot of product.

4. Meeting regulatory compliance expectations

“Data Integrity isn’t a concern on paper…” – Have you also used this argument? If you didn’t document it, it didn’t happen. Paper processes can be rife with errors, or omitted data. Electronic systems compel the users to enter the necessary information before the user is allowed to progress to the next step. Effective system design combined with OOTB audit trail functionality in the eQMS solutions alleviates many paper process data integrity issues before they can occur. The audit trail is presented as a robust report, including all of the applicable data about who made a decision to move forward and when the decision was made and what the justification for making the decision. The Audit Trail functionality has been developed as a part of the best practices to meet regulatory compliance expectations. And as such, auditors are more familiar with the solutions and less time is spent looking into the functioning of the system.

In summary, implementing an eQMS for your compliant life sciences business provides a number of beneficial results. Value in the implementation of and eQMS will be found in greater efficiency, fewer errors, and major improvements in reporting. Beyond these improvements, many more opportunities are available including integrations with other systems, improvements in user access and manging user acces, and the potential to incorporate paper processes from other parts of the business. Please find more information on our website.

About the author

Alicia Whitney has been working with compliant, validated computer systems since 2010 when she started her career at a small pharmaceutical company in Pennsylvania, USA. Collaboratively implementing and validating document management, quality management, and inventory management systems, she has gained knowledge and experience in many areas of the pharmaceutical industry. Since joining fme Life Sciences in 2018, Ms. Whitney has continued to provide an experienced perspective when gathering requirements and guiding assessments for client implementations. Ms. Whitney continues to build on her experience, now holding certifications on TrackWise Digital QMS and VeevaVault Platform.

Managing CRO Sponsor Compliance in Veeva Vault Clinical

Managing CRO Sponsor Compliance in Veeva Vault Clinical

We also highlighted the importance of having a full picture of your outsourcing strategy as a small-to-midsize clinical research Sponsor. The activities to be performed and the systems of record to be utilized by the Contact Research Organization (CRO) drive our approach for oversight and governance – the essential compliance aspects of eClinical systems in the clinical operations space.

For example:

  • Will the CRO use their in-house eTMF system, work exclusively in the Sponsor eTMF, or a combination of the both?
  • Will the CRO systems/reports integrate with the Sponsor CTMS to capture enrollment metrics or other pertainant, strategic clinical data points?
  • What is the cadence of document and information sharing expected (i.e. Quarterly, Annually, End of Study)?

With this healthy foundation – simplicity and awareness – we are primed to tackle two key components of long-term eClinical system success: oversight and governance.

Oversight doesn’t have to be a complex process

First, let’s box in exactly what a Sponsor is obligated to under the FDA requirement of ICH E6, Section 5.2:

5.2 Contract Research Organization (CRO)
5.2.1 A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.

ADDENDUM
The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).

Put simply, the Sponsor must ensure that there is appropriate oversight and the evidence of the oversight needs to be retained. If the CRO didn’t do something or didn’t execute in the agreed upon manner or timeframe („specified in writing“ as required in 5.2.2), the Sponsor continues to bare the risk for the breach or underperformance.

As we can see in 5.2.1 of ICH E6, the CRO does have an obligation to implement (1) quality assurance and (2) quality control measures; as the Sponsor, these are our items of focus for oversight.

Is the CRO executing in alignment with these things:

  • Quality Assurance – the overarching quality management concept that relates to how a process is to be performed, and uses a proactive approach to prevent quality issues from arising
    (i.e. work instructions, process checklists, standards to be met in order to approve a document)
  • Quality Control – a reactive measure used to detect defects/deviations from defined processes and the steps taken to capture (documentary evidence of issue identification process and remediation steps) and correct any issues
    (i.e. mock inspection, QC Review workflows, logging Quality Issues on documents and routing for remediation).

Now that we know what is required, let’s talk game plan. Oversight doesn’t have to be a complex process – just set the cadence, determine the sample size, and, like your 3rd grade math teacher used to say, no points awarded unless you show your work!
Start with what is feasible, given the applicable outsourcing model and regulatory history of the organization (annual, staggered with Veeva Vault releases (3x yearly), etc.). Determine the subject matter to be reviewed and create a simple, user-friendly format to capture CRO oversight activities. This should include the remedial measures taken to correct any issues; to follow through with those measures is key, and should be incorporated into the next round of CRO oversight (if not completed sooner).

 

 

How to create a simple, painfree governance framework

Governance can be an intimidating concept! Given Veeva‘s 3x annual release schedule and associated impact activities for each one, where do you even start? The most common challenge that small-to-midsize organizations face is optimizing limited resources – how do you find the time to develop a strategic system management plan, create structure and process to support that vision, and then, actually execute on it?

The good news? In the exasperation, is the answer.

Let’s break it down:

1. Develop a strategic system management plan.

a. What we do now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

b. What we want to do 1 year from now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

c. What we want to do 3 years from now

i. CRO Oversight
ii. Veeva Vault Releases
iii. Program-Level Support

2. Create structure and process to support that vision.

a. What are we doing now that works?
b. What are we doing now that doesn’t work?
c. What needs to change to get us to the Year 1 goal?
d. What needs to change to get us to the Year 3 goal?

3. Execute on it.

a. Start with what is within your control. Lay the groundwork to persuade others toward your future vision, then embrace the evolution of the strategic vision.

By answering the above questions, you’ll create a simple, painfree governance framework; a good foundation from which to build and mature, tailored to your organization‘s specific goals and needs. And, if task 2 „Create a structure and process to support that vision.“ was a tricky one, not to worry. We’ll dig deeper into that specific topic in our upcoming blog post: „Data Discernment – A simplified approach to strategic planning“ – stay tuned!

About the author

Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.