Finding a Needle in a Haystack: Enhancing Visibility in Clinical Service Provider Management

Anca Copaescu

CEO and Founder of Strategikon | Visionary in Clinical Outsourcing and Vendor Performance Management

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Strengthen your processes and increase data-driven decision-making for faster study start-ups.

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Strengthen your processes and increase data-driven decision-making for faster study start-ups.

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It’s an interesting phenomenon: the bigger the biotech or pharma company gets, the muddier the landscape of vendor performance management, regardless of the category: clinical, or non-clinical, services or goods. Curiously, this is despite the fact these organizations invested hundreds of millions in preferred partner programs, custom-build solutions and infrastructure to support vendor management, with the goal of driving transparency.

Operating in the current landscape affords less visibility than ever. The more systems that are in place, such as QA system, general procurement, qualification, surveying tools, eTMF to name just a few, the more the ubiquitous Excel tracker becomes the “connector” of silo-ed initiatives, departments, and systems. And the higher the user frustration goes.

What makes management of clinical service providers such a paramount challenge?

At Clinical Maestro we have conducted hundreds of interviews with vendor management leaders and subject matter experts in strategic partnerships, alliance and category management, clinical outsourcing and procurement and found that at different levels, all are being challenged with “finding a needle in a haystack,” uniting key information about their vendor portfolio for actionable decisions.

There seems to be a recurring theme. Too many disjointed systems, too many owners, too much effort in managing vendor performance and ultimately, too few analytics are available to detect risks early and support compliance to regulatory oversight. There are many reasons underlying the problem and chief among them seems to be the ever-changing nature of clinical trial management combined with increasing complexity of services offered, a multitude of decision makers, sometimes operating in silo, and intense M&A and rebranding activities in the vendor marketplace.

Here is a simple example that describes the myriad of “go to places” for vendor management information. Vendor profile, including contacts, may be found in procure-to-pay, contract management, QA, diversity tracking marketplaces, Outlook, business cards or Excel trackers. Each source contains slightly different and sometimes conflicting information and, requires updating by disparate users. There is no standardization in category management. We’ve seen sometimes as many as 5 different categories for “labs.” Oversight and governance plans, meeting minutes, KPIs are often handled by both vendor and biopharma company and are often stored in SharePoint, occasionally in the eTMF or QA system, or both. Since outsourcing activities are largely manual, e.g., Excel-based RFPs, proposals and email communication, sourcing activity at the study level is often kept in trackers or documents folders and contract information may be in a contract management system. This is further complicated by the fact that some biopharmaceutical companies operate in a “full-outsourcing model.” This means the CRO may subcontract services, such as eclinical systems, so the vendor, contract, sourcing and performance information may be stored in the CRO management system, not the Sponsor’s. Business qualification and onboarding information may be kept in Excel or Word-based RFIs, surveying tools, or generic procurement solutions. Risk management information such as “lessons learned”, quality or performance concerns
are often kept in “issue trackers”, eMTF or QA system. A single vendor is “touched” by accounting, finance, procurement, QA, sourcing, vendor management, project management, and study team members. Each having its own “go to” system or tracker. So, no wonder that trying to answer a simple question such as “How much business do we have with CRO A?”, or “Who are the vendors for study B” is non-trivial.

When we embarked on building VISION, we wanted to achieve 3 main objectives: create a central repository for all vendor information, either as the primary information holder, or by integrating with other systems; simplify access to vendor information by directly navigating into a single source of truth; and create a solid analytical infrastructure to contain and minimize vendor portfolio risks. We laid out the path to success by approaching vendor management from multiple perspectives: category management, business qualification, performance, and governance. To expedite access to study-level sourcing information we integrated VISION and SOURCE by design to provide the maximum visibility into outsourcing history at granular level.

The result? A super-powered, agile, AI-fueled, process-enabling vendor administration database, connecting the myriad disconnected systems and silo-ed internal stakeholders as well as the vendors.

By sharing access permissions into a common platform for information, we are achieving unprecedented levels of visibility into outsourcing activities and transparency in relationship management. VISION is becoming the unifying heart for procurement, QA, partnerships, and study teams.

Best of all? Through customer-led product advancement and thought leadership, industry experts have come forward to create a visionary product under the Clinical Maestro umbrella and are now using it to transform category and performance management. Now ‘finding the needle in a haystack” is a non-issue. As the old saying goes: “Where there is a will, there is a way”

 

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