• Protocol Review – Based on our experience with many protocols, we evaluate the proposed protocol for consistency, simplicity and items that may hamper enrollment or make the protocol more difficult than that which is necessary to reach the desired end points. Depending on the protocol, we are usually able to provide a written report within 5-7 days.
• Simulated Patient Site Training – We use a training method similar to that we are using in our GCP courses. Simulated patient charts are provided with the expectation that these sites will complete the enrollment and study documents including a CRF. Prior to producing the simulated cases we meet with the sponsors/CRO to discuss what scenerios would be appropriate. It is important that we try to include a number of key points of emphasis inherent to the protocol such as protocol-defined AEs and certain situations that might require different action. In this way the site not only learns how to categorize the patient and complete the CRFs, they also learn to deal with the anticipated pitfalls and complications unique to that particular study.
• Dry Run Protocol Pilots – These early stage assessments and are essentially a simulated pilot run of the protocol involving generally between 1-12 mock patients. This can be complemented by early stage protocol evaluation. This is essentially an in-house mock enrollment project.
• Study Review including Protocol CRF – This goes beyond the first item of protocol review and looks at how well the CRF and other study documentation meshs with the protocol.
• Early Stage Protocol Assessment – This is similar to the dry run protocol policy but without simulated patients. We evaluate the feasibility of the protocol including suggestions on changes that may help manage costs and ensure a high degree of valubility and subject retention.
• Site Mock Patient Enrollment – This is similar to the simulated patient site enrollment but it involves a more interactive environment. Rather than having the source documents provided in a complete form for evaluation and entry into the CRF, patients are evaluated. This is generally done by using live individuals. It may also be done at investigator meetings using small groups and a number of “actors.”
• Adjunctive Services Evaluation – For this process we evaluate the function of the adjunctive services such as EKG and radiological services, RDE/EDC products, IVRS and other interactive randomization products. We have seen a number of protocols that have done poorly because of the adjunctive services, pampering enrollment and in one case, causing the study to be stopped temporarily despite an excellent protocol.

In addition to the services referred to above, we also provide investigative sites, which is what we are best known for. We offer education and training to PIs, subs and others in need of training both in GCP and the conduct of trials. Other services include post-approval marketing programs with studies that have, in addition to a scientific interest, a desire to breed familiarity with the particular product. There is a clear body of evidence that demonstrates that physicians who use a product in a trial generally will continue to use an efficacious product in practice. We also provide a limited audit function which we would be happy to discuss in more detail.

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