Once proof-of-concept testing has been completed a product safety plan is developed and, assuming limited in-house testing capabilities of the client, a qualified Contract Research Organization (CRO) must be selected for completion of all (or part) of the preclinical testing. Walker Downey & Associates, Inc. has an extensive database of qualified CROs by product type and study type and will typically broadcast a Request-for-Proposal (RFP) to these select organizations based on an agreed upon concept protocol. Key components of the RFP communication include study timing (the client’s preferred study initiation date), duration of testing and reporting, and study costs. Because of our preferred status with these CROs we can typically receive priority study placement to meet your study timing needs. Our preferred status also means that the CRO will provide a competitive pricing without compromising study quality. Walker Downey & Associates, Inc. will justify a CRO recommendation to the client but the final selection decision remains with the client.
CROs offer a variety of services and may have a broad range of competencies for evaluating and modeling various diseases and disease states. Services may cover protocol design, optimal animal models, regulatory relationships, GLP compliance, study competencies, data review and analysis, or standard or unique techniques. A focus in a particular therapeutic area requires an appropriate assessment of expertise, skills, and technical competencies.
Large CROs have a history and reputation in the marketplace as do smaller, more focused but less widely known CROs. As studies are initiated, clients need to assess all options regarding CRO quality and reputation.
Following selection of the CRO a study monitoring activity is initiated. In this phase Walker Downey & Associates, Inc. serves as an authorized Sponsor Representative, approving the study protocol and all study activities through study reporting. Study monitoring activities typically include attendance at the protocol kick-off-meeting (i.e., a protocol question and answer session including the Sponsor Representative, Study Director, and lead study technicians) on-site phase audits of critical activities (e.g., treatments, sacrifice), both scientific and for quality assurance. Walker Downey & Associates, Inc. will also coordinate the review of the final study report for your approval.
While there are many advantages to outsourcing there are areas of concern to consider. Medical device, biotechnology and pharmaceutical companies may encounter problems when selecting an outsourcing opportunity such as:
Walker Downey & Associates, Inc. has an in-depth knowledge of the preclinical marketplace, thus access to this critical information means improved CRO selection. Additionally, this means a reduction in risk, expense, and a faster time to market. Walker Downey & Associates, Inc. will help select a preferred provider by:
Walker Downey & Associates, Inc. has many repeat clients for this aspect of our service offerings, including our preferred vendor status with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Contact us to see how we can save you costs and accelerate your product development time line.Case Studies