The following formula about clinical trials won’t appear in any textbook, but it is very real for small- to medium-sized pharmaceutical and biotech companies:

Overworked staff + multiple clinical trial vendors = loss of time, money & control

While that formula has seemed intractable in the past, it is now yielding to a different solution based in a relationship shift with CROs (Contract Research Organizations).

The Dilemma for Smaller Pharma/Biotech Companies

Large pharmaceutical and biotech companies either find and manage their own vendors for clinical trials or hire a contract research organization (CRO) to take over the relationship between sponsor and vendor. According to some estimates, 70% of clinical research services at the leading pharmaceutical and biotech companies contain at least one outsourced component. The major CROs create a single point of contact between sponsor and vendor, simplifying contracts, change orders and communications. Their services are costly and add another layer of bureaucracy. However, large pharmaceutical and biotech companies have the staff, money, time and leverage to either handle vendor management themselves or provide oversight to the CRO and make sure their requirements are heard.

But small- to medium-sized companies don’t have this luxury.  They can’t afford the overhead associated with hiring major CROs, and they would be forced to accede to the CRO’s terms, including site selection, patient selection and management practices.  If a company instead attempts to handle the clinical trial process themselves, then their overwhelmed staff can easily lose financial and management control over multiple vendors.

But what if these small- to medium-sized pharmaceutical and biotech companies had access to a new type of CRO — a world-class CRO that understands the financial, legal and organizational pressures they work under, including their need to exercise reasonable control?

The New CRO Relationship

For smaller companies to reap the benefits of the CRO relationship, the CRO itself has to meet three important criteria:

1. First, the CRO has to have its own stable team of trusted clinical research professionals with proven ability to work together with minimum bureaucracy.
2. Second, the CRO must have long-established connections to proven sites and vendors across the world, without any contractual obligation to use those vendors on every clinical research study.
3. Finally, the CRO must want to work with small- to medium-sized pharmaceutical and biotech companies. It must be comfortable with staying small and agile like its sponsors.

By combining stability, flexibility and transparency, along with proven research management skills, the new style CRO ensures that their services meet the sponsor’s performance requirements.

The new style CRO offers all the advantages provided by traditional CROs without the resultant bureaucracy, rigidity and costs. It is able to:

• Select the best vendors and/or work with vendors specified by the sponsor
• Handle all legal, financial and management relationships with vendors
• Provide a single project manager interface
• Ensure clear communication with every stakeholder at every stage
• Provide a risk-sharing arrangement when appropriate, with rewards and penalties based on the quality of the research management (achieving results within timeline and budget).

When the CRO model is within the grasp of small- to medium-sized pharmaceutical and biotech companies, an entirely new formula appears for clinical research success.

Where Confidence Pharmaceutical Research Fits In

The history of Confidence Pharmaceutical Research stretches back over 30 years of impressive clinical research in Europe, the Near East and the Americas. Our stable team of medical and management professionals include clinical research associates (CRAs) who have worked together in over 200 studies across those decades. Our experience spans cancer, auto-immune, diabetes, pulmonary, neurology, gastro-intestinal, nephrology, orthopedic, orphan diseases, pediatric, psychiatry and cardiovascular studies. We have a stellar record for achieving patient recruitment targets, strictly adhering to protocols and delivering clean data on time and on budget.

Is your company a small- to medium-sized pharmaceutical or biotech company? Are you in the clinical trial planning stage, or now launching a trial, or struggling with under-enrollment, or in need of rescue? Then contact Confidence Pharmaceutical Research today, and begin writing your own new formula for clinical trial success.