Clinical vendor oversight doesn't have to break the bank

The responsibility of vendor oversight

The clinical trial space is no stranger to the requirements and guidelines from regulatory agencies.  In fact, regulatory compliance is the backbone of the entire quality management paradigm. One of the critical components of compliance is oversight and monitoring.  Surprisingly though, vendor oversight is often overlooked due to limited employee bandwidth or sometimes lack of expertise.  

There has been plenty of attention given to the idea of vendor oversight over the years.  In particular after the release of ICH E6 (R2) in 2016.  Section 5.2.1 specified that, "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."  In short, that means that even if a biotech or Pharma company contracts with a CRO, and by extension a clinical trial technology provider, they still need to ensure that there is a robust oversight plan in place. 

More recently, as illustrated in the updated ICH E6 (R3) draft, the direction has been more explicit.  Section 3.6.10 states, "The sponsor should ensure appropriate oversight of important trial-related activities that are transferred to service providers and further subcontracted."  So while the industry and regulators have been clear, the challenge still persists.  Who has the time and the expertise to provide the oversight? 

Shifting employment trends provide new opportunities

While significant changes were seen across services providers, CROs, and sponsors during and after the pandemic, the general concept of employment didn't change; rather, the industry saw a sort of shell game of employees swapping out current employers for new.  More recently though another shift has occurred where companies have been adapting or in some cases correcting internal cost imbalances.  That's a nice way of saying employers are cutting jobs.  The reduction in internal head count doesn't necessarily come with a reduction of work; and in particular, there is no reduction in the need for vendor oversight.  

The old saying, "When one door closes another one opens" rings as true today as ever.  Many of the same employees that have recently seen their roles eliminated do to cost cutting measures now find themselves in the exciting new world of contracting.  What is even more interesting is the number. of companies who were forced to move from a fixed cost model (salaries and benefits) to variable cost, as contractor expenses can fluctuate based on the work required and performed.  This means that in many cases, an employee's job hasn't changed at all, in fact they still may sit in the same desk and report to the same manager.  All that has changes is that the employee no longer works directly for the company, thus the shift in how costs are reported to investors, shareholders, or other interested parties.  There are of course many individuals who experience a more abrupt change in a reduction of force, but those people are learning that working as a consultant or contractor has significant benefits to their own quality of life and job satisfaction. 

Supporting oversight with fractional expertise

Given the expanded pool of employees that are available for fractional (a.k.a. part-time) work, in conjunction with the recent boom in remote employment, there is no better time to take advantage of the deep expertise that exists.  To better understand what this could mean to you, let's provide an example.  In this instance, we will use IRT/RTSM, which is a technology solution to manage the randomization of patients in a clinical trial as well as the clinical trial supplies.

Problem:

A biotech company has a new product that is going into a pair of phase 3 studies.  These studies use the same drug across two different indications.  They used a smaller provider in their early phase studies but don't think that provider has the capabilities to manage two global phase 3 studies.  In their early phase studies, the clinical program manager was responsible for all of the activities related to clinical technology, but with the expanded scope of these phase 3 studies, the program manager won't have the capacity to manage the technology providers moving forward. 

Needs:

The biotech needs to run a clinical outsourcing event to gather information about potential suppliers.  They also need to qualify the provider, of have them qualified by their CRO, before the study starts.  After the provider is selected, the biotech company will need to attend design meetings, review and sign off on specifications, conduct UAT (user acceptance testing), and then monitor the system and it's identified critical data throughout the life of the study.

Solution:

Leverage the availability of fractional experts, with deep and specific subject matter expertise.  These part-time resources have industry experience to streamline the vendor search process, years of experience in managing and building relevant technology solutions, and valuable insights to the nuances of clinical vendor and data quality oversight.  Since these individuals are available from a few hours a month thought a few hours a day, all depending on your need, you don't need to add new fixed cost for internal head count.

How BC Consulting can help you

At BC Consulting Group, we specialize in connecting professionals that need support with those who are equip to provide it.  Our eClinical consultants fit roles like the one outlined above perfectly and provide Biotech and Pharma companies with flexible resourcing solutions that can adapt and scale up and down as needed.  If you are interested in learning more about how our eClinical experts can help you in your mission to provide critical clinical vendor oversight, contact us today.  Our team has deep experience a many technology systems like EDC, IRT/RTSM, eCOA/ePRO, eConsent, and much more.