Consumer awareness of the quality of goods purchased is good practice in any industry, but in biotech and pharma, it is a regulatory requirement. One of the most common goods we purchase in this industry is a vendor’s services — their time, effort, and resources. Whether it be a lab, CRO, or data management group, the FDA mandates we, as sponsor companies, know the quality of the goods and services we purchase from them.

The Current Process

The standard practice for getting to know the quality of these goods and services is to perform an audit of the vendor before working with them. This includes a basic qualification audit (typically a review of the organization’s structure, facilities, SOPs, training records, computer system validation, etc.) as well as an audit of their specific capabilities as they relate to your company’s needs. Outsourcing has become increasingly popular over the last few decades, creating an industry that is saturated with the use of vendors. This trend forces sponsor companies to perform and re-perform qualification audits to stay compliant but doesn’t necessarily demonstrate the vendor’s ability to be a solid performer once the project is awarded.

There are quite a few issues posed by this traditional method of qualification. One is that qualification audit agendas are largely the same among each sponsor company. Therefore, the outcomes of the audit discussion questions should be the same. How many times can we find one vendor to be Part 11 compliant? What can be learned from this activity that can accurately predict an issue with performance or oversight with any reliability? Another problem is that auditors are often severely underqualified or undertrained, and what they have the capabilities to audit may not be a solid match with the activities being outsourced.

This adds up to a shocking number of audits conducted each year when considering the almost 4,000 CROs in our industry.1 Recently, we conducted a survey and found the majority of midsize to large CROs estimated two audits per month. Each audit examines almost exactly the same set of documents and asks virtually the same questions. This necessitates repetitive activities that keep the CRO’s team busy for an average of 29 hours per audit.

Aside from consuming many hours of the CRO’s time, we also heard some auditors don’t take the job seriously. One CRO’s quality leader told us two junior auditors spent the entirety of their two-day visit watching cartoons in a conference room.

All of this presents quite a problem when considering a typical vendor qualification audit costs between $10,000 and $20,000 of non-billable time for the vendor to prep and follow up. Calculated annually, the cost is at least $240,000 spent by each company on “check-the-box” activities. While this is not factored into a specific line item in a proposal, it does contribute to the overhead costs that are built into every project. Consuming resources at this level when activities provide little value does not guarantee a successful engagement. It is actually counter to the risk-based approach contained in the ICH E6(R2) guidances, because it consumes precious resources with little risk reduction.

Public Accreditation Program

An alternative method of qualifying vendors is bubbling to the surface: a specific accreditation program for vendors shared and accepted by sponsors. This would be a program built and run by a body of independent industry veterans. They would perform their due diligence on well-known, frequently engaged vendors in the industry and put their stamp of approval on those that meet the basic standards required by the FDA. This is not a novel idea — programs like this already exist in other industries, including the manufacturing of clothes, toys, footwear, and general household products as well as in the manufacturing space for life sciences vendors and IT firms. But it is a novel idea for clinical stage vendors — an industry which is so strictly regulated, yet with such little value currently extracted from the qualification process.

The Vendor Perspective

Irving Dark, senior vice president of clinical research services at Cytel and a pioneer of this idea, believes success is contingent on buy-in from all parties, including vendors. “Vendors should be onboard when they realize time saved here can then be spent on making sure every touch with a customer is exemplary,” Dark said. “It is good for the industry but also great for business.”

Peter Benton, president of Worldwide Clinical Trials, agreed, saying, “We spend hundreds of hours a year doing things that ultimately add little to no value to the conduct of the program, its deliverables, or the strength of our relationship with clients. Our goal is to do what really matters to the client, hence our enthusiasm for this concept.”

Do you pre-qualify your CRO for GCP compliance?

Not completing an audit, or performing a sub-standard pre-qualification review, is extremely risky and puts all of your clinical efforts in peril of being non-compliant.
Check out Michael Pierro’s webinar, “Conductiong the CRO pre-qualification Audit for GCP Compliance – Key Risk Factors to Avoid” to avoid inevitable headaches.

The Sponsor Perspective

If your company could trust that this new group was sending qualified individuals to perform diligent, thorough audits, there would be no need to duplicate the basic qualification audit with the vendor. Instead, you could focus your time and effort on the specific operations of the company that relate to your business and the relationship you are looking to form. This would be a better indicator of a potentially successful business relationship. In addition, taking a risk-based approach to quality activities would enable the QA group to manage higher-priority compliance issues that ultimately can impact data quality or create challenges at pre-approval inspection.

Kathryn King, VP of clinical research at Levo Therapeutics, has experience working in both large pharma and small biotech. She believes small companies with limited resources would likely be quick to hop onboard. She stressed, “It may take longer for bigger companies to realize the value, but taking qualification one step further to include a comprehensive type of risk-based ‘pre-inspection preparedness’ would likely push them over the edge.”

Margo Holland, executive VP and  global head of quality at Worldwide Clinical Trials, has vetted this idea with clients, sponsors, and other industry players. She found “nearly everyone agreed this idea is brilliant — a checked box.” The time repeatedly spent preparing for audits, hosting auditors, and then following up on findings that may be ultimately irrelevant to overall quality or performance is significant and adds little to no value.

The last thing clinical development teams at CROs ever wish to hear is this response from their sponsor colleagues: “You are the company we want to run the trial, but we have to get started right now and we can’t afford to wait to get a qualification audit done.” You, as the pharmaceutical or biotech company, are ultimately responsible for ensuring the quality and control of outsourced activities. If we could find a cheaper, more reliable, more comprehensive method of doing so that also lends itself to inspection preparedness, how could we pass it up?

A focus group is being planned to gain consensus on a process for going forward, after which we will publish a paper on the next steps. We welcome your participation. Please contact us at marketing@hallorancg.com.

References:

About the Author:

Laurie Halloran founded Halloran Consulting Group in 1998. She has built a consultancy of like-minded experts who are dedicated to the idea that every company deserves the best practices and know-how in the life sciences world, regardless of its size, name, or financial situation. She is recognized as an industry expert in improving the organizational effectiveness of those companies.

Earlier in her career, Halloran worked in the outsourcing services realm during PAREXEL International’s rapid growth phase, where she developed competency-based programs for several departments within the organization and led the integration of the company’s European operating units acquired during her tenure. She later led clinical development at OXiGENE and Antigenics.

Halloran taught at George Washington University and Harvard University and currently lectures at Boston University Medical School and the Tufts Center for Drug Development post-graduate program. Halloran earned a B.S. in nursing from Russell Sage College and an M.S. in management from Lesley University. She is also a Prosci Certified Change Practitioner.

Leave a Reply