How to Vet the Best Consultants for Your Project
By Joseph Pierro, chief medical officer of Biomedical Systems.
In the clinical research industry, no two projects are identical. As such, each project’s requirements vary widely across programs, sponsors, and even continents.
What remains the same, though, is the need for highly qualified, experienced, and trustworthy clinical consultants to ensure that any given project is completed efficiently and successfully. What also remains the same is the challenge of finding and selecting the right consultants for your next clinical study or drug trial.
The Role of a Clinical Consultant
Consultants are invaluable contributors to clinical project teams. A consultant helps improve a development project’s design and implementation by defining the study protocol, assessment processes, and more. Their proficiencies can range from general knowledge — like overall project support and management — to more specific areas, like clinical site monitoring, medical monitoring, statistical expertise, or specialized expertise on the subject matter or class of drug. Experienced consultants also have viable working knowledge of the clinical study process, including the methods that work best (and those that will only waste the project team’s time).
The good news is that finding reliable, highly qualified consultants is not as difficult as it may seem. Though the clinical research industry is global, it’s still small and well-connected. Chances are at least one of your professional connections has experience with an appropriately skilled consultant (or can at least connect you to a referral).
Vendors and contract research organizations (CROs) are other valuable channels for outsourced expertise and provide relatively easy access to trusted consultants with a wide variety of skills and experience. With the right referral from a CRO, you can quickly enhance the project team’s level of experience, as well as the productivity and quality of the project itself. According to the Association of Contract Research Organizations, outsourced consultants could reach between 60 percent and 80 percent infiltration in the pharmaceutical industry in the distant future.
No matter who recommends the consultant, however, it’s vital you properly vet the candidate to determine if he or she is right for your particular project.
Trust, But Verify
Finding a pool of potential clinical consultants is the relatively easy part. Now, you must identify and verify the candidates best suited for the project’s requirements.
The first step is due diligence in the screening and review process. Perform a web-based network search for each candidate’s online business website (if available), professional profile, and online publication. You can use the PubMed search engine to perform a MEDLINE database search of a potential consultant’s publications, abstracts, and references.
Next, request the candidate’s current curriculum vitae. Carefully review it against the levels of education, training, and work experience needed to meet the study’s specific requirements. Keep in mind, though, that smaller startup companies may have a high degree of title inflation (like executive titles) that don’t compare to the responsibilities of similar titles in mid- to large-sized pharmaceutical companies and CROs. Therefore, it’s important to thoroughly understand how a consultant gained experience relative to the therapeutic area, class of drug, or regulatory guidelines involved in the project.
You can gain a clearer picture of a candidate’s experience by reviewing his or her professional and educational accreditations, advanced degrees, and supplemental training certificates. This may include specialized medical training, accreditation through Regulatory Affairs Professionals Society or the Accreditation Council for Continuing Medical Education.
Finally, be sure to review every potential consultant’s client listings, affiliations, and agreements to determine if they present a conflict of interest. This step is often overlooked, and can cause significant setbacks after the project is already under way.
Seal the Deal
Once you’ve identified the right clinical consultant to proceed with, the next priority must be to reach an agreement. Before proceeding to the final contract process, make sure the consultant’s roles and responsibilities, project expectations and timelines, deliverables, remuneration rates, and the length of the contractual obligation are clear. The consultant should be fully informed before making a decision to engage and commit to your project team.
Open communication helps guarantee transparency from both parties to ensure a solid foundation for your relationship with the consultant. It should be noted that both parties should sign a confidentiality and nondisclosure agreement before openly discussing the specifics of the project.
The concluding step to selecting the right consultant is to produce a contract clearly outlining the scope of work, specific deliverables, and obligations expected of the consultant. Both parties should review and sign the contract well before the start of the project, so allow time between consultant selection and the project’s expected start date.
Though the right consultant’s services may be more expensive, the investment is sounder and more profitable than choosing a consultant who lacks the skills and experience necessary to successfully complete the project.
Joseph Pierro is chief medical officer of Biomedical Systems, a premier global provider of centralized diagnostic services. He has served in global senior level positions within the pharmaceutical industry and as a medical reviewer at the FDA Center for Drug Evaluation and Research. His thorough understanding of regulatory submission requirements and outstanding track record of success with regulatory approvals and responses to regulatory authorities make him an asset to Biomedical Systems’ Scientific Affairs team.
