“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.

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.

Reducing the “noise” – How to tailor Veeva Vault Clinical to your individual needs

Reducing the “noise” – How to tailor Veeva Vault Clinical to your individual needs

With this blog article I am taking a closer look at how CRO Users and Activities are managed in Veeva Vault Clinical and deal with decision-making re: who from CRO can/should have access to eTMF/CTMS in Vault, what activities are performed in Sponsor vs. CRO eTMF, and how you can tailor the system according to your needs to avoid functional overload. In my next blog I will talk about Inspection Readiness – “Managing CRO and Sponsor Compliance in Vault Clinical” and part three will cover the topic of Integration and Reporting – “Data Discernment – A simplified approach to strategic planning.”

Moving to a cloud-based eTMF and/or CTMS is a big step, particularly for a small to mid-market life sciences organization. The budget to secure and implement eClinical technology typically coincides with a strategic shift by company leadership, often leaving clinical teams feeling pressured to support visibility and engage deeply in a new system. A key challenge is balancing the existing outsourcing model (spend, system integration, and study activities) with the capabilities of the new system(s).

How to find the right balance of streamlined configuration and intentional user access

Here are a few important questions to ask as you determine the right fit – a balance of streamlined configuration and intentional user access – for your organization:

First, do you know your outsourcing strategy? Learn it. Read the contract, request the scope of work or a synopsis thereof:

      • what is the CRO scoped to do?
      • is it on a study by study basis OR 80/20 consistent activities OR other?
      • is work done in CRO or Sponsor environment per the scope of work/contract?

Second, align the supporting documents:

      • what does the CRO Oversight Plan say about system work?
      • if there is no CRO Oversight Plan, make one.

Third, observe what is actually happening with your CRO partners:

      • is the CRO performing in accordance with the scope of work as it relates to system activities?
      • does this CRO user need the level of access that they have requested?
      • if not, what steps are being taken to communicate, mitigate, correct, and document?

Now that we know how the CRO is contracted, we can address what the Sponsor system should support. It’s challenging for many small and mid-size Veeva customers to effectively tailor their Veeva Vault experience to the actual work being performed in the Vault environment. Keep in mind that Veeva Vault Clinical is intentionally designed to support a broad customer profile – biotechnology, medical device, and pharmaceutical companies in ALL phases of research and commercialization, across ALL indications. The out of the box offering is powerful, dynamic and comprehensive, but can also be overwhelming!

 

 

Reducing the “noise“ – Tailoring the Veeva Vault Clinical environment to your individual needs

Of particular importance for small to mid-size customers is to tailor the Vault environment – not by adding new configurations, but by strategically turning off features that, while beneficial, act more as noise and barrier to end-user adoption.

For example, if you utlilize a full-service CRO (one that performs most study activities), a Sponsor CTMS runs the risk of capturing duplicitous, out of date data, not to mention the resourcing burden for Sponsor with ingesting superfluous data.

The key question here is: what data elements do I need as the Sponsor to support (1) compliance and (2) the strategic portfolio?

Many out of the box fields in Vault CTMS are not required for an outsourced Sponsor and may create more “noise“ than potential business benefit. If the CRO provides a weekly report or output from their CTMS, it may be more beneficial to integrate or ingest their data rather than utilize scarce resources to perform duplicate data entry, particularly if these data points are not currently actionable or used.

Features to consider:

    • Expected Documents / Expected Document Lists
      • Are we collecting the Expected Documents or is the CRO collecting, then updating the Sponsor eTMF (or sharing a weekly/monthly report)?
      • Can we eliminate or reduce the template EDL to better support our oversight activities, rather than duplicating work already done by the CRO?
    • Milestones
      • Are the template Milestones relevant to our internal processes?
      • If not, let’s turn them off or simplify the Milestone Template to align with our process and create a more useful, purposeful user environment.
    • Workflows
      • What document processes are actually taking place in our eTMF or CTMS?
      • Do we need all of the possible out of the box workflows available to users or is it causing confusion?
      • If we don’t need all available workflows, let’s turn them off so that users have only the relevant business processes available when actioning a document in the system.

The technology landscape puts capabilities at our fingertips, but just because we can do something doesn’t necessarily mean that it‘s the right thing, right this minute for our team(s). This simplified foundation provides a system environment primed for agile adaptation, rather than beginning from a place of overwhelm: start simple, then mature the system and supporting processes to meet your company‘s unique needs.

And, lastly, how to determine when to kick things up a knotch. Being intentional is of great importance, particularly in system management. We are the nexus point joining the limitless potential of modern technology with the business user experience. It is our role to facilitate clinical enablement, to make doing the work of bringing drugs, devices and biotechnology to market that much better – faster, safer, and more cohesive!

In our next post, we’ll speak to the unique needs of small to mid-size life sciences organizations as concerns strategic maturity and how that fits into a hybrid governance model, specifically designed to align with Veeva’s 3x annual release schedule. 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.