There are many challenges involved in executing global CTAs and, in turn, performing investigator payments in clinical research, but a number of these challenges can be averted with proper planning and execution in the budget development stage. Determining fair market value (FMV) benchmarks are a vital factor to global compliance with increasing emphasis on regulations including the Physician Payments Sunshine Act, the Loi Bertrand (the French Sunshine Act), and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code.
Consideration must also be given to the granular details in creating budgets and how those details affect negotiation timelines, payment terms within the CTA, and subsequently, performance of investigator payments to negate a number of complications, including:
1. Delayed negotiations due to lack of transparency in relating budgets to the study protocol;
2. Unfounded benchmarking for country, phase and indication-specific costing, resulting in lack of interest in study participation;
3. Setting future precedents for unreasonable budget negotiations and increasing costs;
4. Inability to perform payments as a result of budget visits and ad hoc costs not aligned to CTMS required amendments to CTAs and further study delays; and
5. Improper payments to sites creating potential compliance issues and extensive reconciliation resulting in delayed study data collection for data base lock.
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