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The drug development process requires constant accelerating of the study timelines and getting data to the regulatory submission on time. At Diverse Lynx, we provide access to highly selected resources in clinical trial management, regulatory, safety, data management and biostatistics, in USA and overseas.
Diverse Lynx is geared toward coordinating the Investigator meetings and creating a dynamic environment for the interaction of individuals for a common cause of developing the drug. This meeting is designed to provide an overview of protocol, good Clinical Practice and study-specific clinical, regulatory and project management procedures. From scientific presentations to project management, meeting services, creative design and production, Diverse Lynx aims to conduct meetings that are engaging and effective.
Monitoring & Supervision
Customers universally recognize the value of investigators who are able to recruit patients and provide 21 CFR 11 compliant clinical data in a timely fashion. Obtaining quality data that meets international regulatory standards and compliance with the spirit of GCP ethics (informed consent process) is of supreme importance to us at Diverse Lynx. Our investigator and site staff play a key role in ensuring that patients are recruited, protocol is followed, and data is reported in accordance with the sponsor's expectations. Our track record for compliance is unblemished.
Site Management
Diverse Lynx provides Site support by its staff, infrastructure, ongoing training and streamlined contractual processes. The Site Management team at Diverse Lynx provides:
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Feasibility Analysis in conjunction with Regulatory & Project management teams. |
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Outcome: Feasibility analysis, site review, preliminary protocols |
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