Clinical contract research organizations (CROs) can be appointed to manage all aspects of a phase 3 trial.
Potential clinical CROs should be evaluated based on their experience in conducting phase 3 trials involving the same or similar indications and their track record – oversight of studies that led to successful licensing applications. Other important sources of information include the results of audits by the FDA and the EMA, references from other companies, and evaluation in industry surveys.
Ideally, one CRO should be responsible for all clinical trial sites in the planned study locations. If this is not possible, multiple clinical CROs can be involved, although this will complicate trial management.
An alternative is to conduct two separate studies in different geographies, each managed by a single CRO. However, this increases the cost and complexity of a phase 3 programme. The sponsor’s regulatory and commercial teams can provide input into a benefit/risk assessment of this approach. It may also be necessary to gain agreement from regulatory agencies if results from different studies are to be integrated to support licensing applications.
The oversight and conduct of phase 3 trials should meet regulatory expectations and specific details should be agreed in advance with the CRO. The sponsor’s clinical development team has primary responsibility for engaging with the CRO, but input from regulatory, quality assurance, and CMC (drug manufacturing and formulation) teams will also be necessary.