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When contracting out critical drug development activities, it is important to choose a well-qualified provider (CRO, SMO, ARO). The right provider can facilitate a compound's development. The wrong one can delay study completion, impair rapport with investigators and, perhaps, even jeopardize regulatory approval. The foremost criterion for choosing a provider is capability, i.e., does the provider have the necessary therapeutic area experience and resources to conduct the project? The number of providers has grown dramatically in recent years. While directories and databases are helpful for categorizing providers, they do not provide detailed information with which a sponsor can evaluate the provider's capability. It is difficult and time consuming for a sponsor to decide which of many providers should be selected for further evaluation by its technical staff. Find qualified providers is a service that utilizes the expertise of John R. Vogel, Ph.D., to evaluate the capability of providers for a specific project. Objectives - Efficiently identify those providers (CROs, SMOs, AROs) that are qualified for a specific project. - Document each provider's experience performing the desired activities in the target therapeutic area. - Provide accurate information on each provider's qualifications. Methodology The sponsor is asked to specify the desired therapeutic area, range of services, and target countries. Dr. Vogel's extensive database is searched to identify prospective providers. Each provider is contacted to review its experience over the past three (3) years conducting studies that are related to the sponsor's area of interest. For each appropriate study, the provider is asked to submit written documentation including: a) study objective, b) number of investigators (sites), c) number of projected and completed patients, d) number of months to complete the project, and e) description of the services provided (e.g., site selection, study monitoring, data management, statistics, report writing, regulatory). The provider is also asked to identify which staff members who conducted these studies are still with the company and to describe the relevant experience of staff who have joined the company since these studies were completed. Providers are requested to submit their documentation within a period of two weeks. The documentation is reviewed by Dr. Vogel who decides which providers will be recommended for further evaluation by the sponsor. The sponsor is sent a report which details a small number of providers (typically three to five) that have the necessary therapeutic experience and range of services required for the project. The entire process, from searching the database to submitting the report, usually requires four weeks. Benefits of This Approach 1. The sponsor does not have to examine a large number of providers, many of which will not be qualified to conduct its project. 2. Documentation on the experience of each recommended provider will be useful to in-house staff in the therapeutic area. 3. The sponsor is presented with a complete package of up-to-date information on each recommended provider, thereby enabling it to quickly conduct follow-up evaluations. Follow-up If requested, Dr. Vogel can work with the sponsor to conduct intensive follow-up evaluations of the finalists, including accompanying the sponsor's team on a site visit to the provider's facilities, checking provider references on past projects in the target therapeutic area, preparing a request for proposal, and evaluating provider bids. [ About
JRVogel ][ Pharmaceutical companies ] [ In-house
training ] John
R. Vogel Associates, Inc.
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