FDA Studies
PGXL is a technology savvy organization with its principals accumulating over 40 years of combined experience in conducting trials for the in vitro diagnostics industry. PGXL serves pharmaceutical and device manufacturers in all of their FDA studies needs. Since the needs of our clients vary based on their organizational size and depth, we have made it possible for them to incorporate our services at various levels in the following areas:
- IRB acquisition. PGXL provides application and protocol writing services for the application of independent review board (IRB) approval of the studies. This may include informed consent forms, HIPAA forms, waivers, and other relevant applications.
- Clinical Validation Protocol Development. Many manufacturers of genetic and pharmacogenetic testing materials have primarily focused on research-use-only (RUO) or similar applications. In addition, the recent interest in wide-spread use of these tests by clinical laboratories has led to the seeking of FDA approval. Due to resource limitation and bandwidth issues, preparation of protocols for FDA studies may be a limiting factor for some manufacturers. Recognizing this fact, PGXL offers to develop specific protocols for your assays using CLSI standard documents, and the FDA’s guidance documents.
- Implementation of Study Protocols. If your organization has existing protocols, or the capability to prepare them, PGXL has the resources and the know-how to implement your protocol in a CLIA-certified laboratory. If need be, portions of the protocol or the entire protocol can be executed at PGXL Laboratories due to its flexibility and cooperative philosophy in conducting clinical research.
- Resolution of Discrepancies. Many unexpected results or issues could arise during the course of conducting FDA studies. In some situations, deviation form protocols may become necessary. Experts at PGXL are there to assist you in getting to the bottom of the issues, and to quickly and meticulously resolve the discrepancies.
- Report Preparation Services. PGXL provides data analysis and reporting services of the studies it conducts. Reporting can be delivered as raw data, or it can be analyzed and reduced into information with final conclusions and recommendations. In addition, select studies can be published in medical literature by the PGXL scientists, with the consent of the study sponsor.