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Diverse Lynx India office is located in New Delhi. We have access to FDA-GCP trained physicians; most of them having super-specialization in the field of medicine. Our office provides added time zone coverage with cost-effective execution of clinical services, data management, and safety and biostatistics services as per the ICH/GCP, 21 CFR Part 11 guidelines. All of the clinical research staff are experienced, fluent English speaking. The facility provides:
Phase I Trials
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We conduct Phase I and Bioequivalence/Bioavailability (BA/BE) studies with Telemetry ,Web enabled monitoring and Secure access. |
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Bar-coding for subject and each of the biological sample |
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Fully equipped ICU for emergency handling |
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Immediate access of laboratory and imaging results |
Phase II, III & IV Trials:
We offer Phase II, III, and IV clinical development programs and lifecycle management. In addition, we offer technology tools for managing the clinical trial data.
Infrastructure:
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Rapid subject enrollment adhered to ICH-GCP guideline |
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Large treatment-naïve patient population accessible through our hospitals |
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Ethnicity diversity of the study subjects population matching with the study protocol |
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Medically qualified and trained investigators (MDs) |
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Highly technical central and local diagnostic laboratories |
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IVRS (Interactive Voice Response System) capabilities |
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Radiology imaging facility (MRI, CT) |
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Cardiology ECHO and MUGA facility |
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Pathology lab facility in India and Germany |
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AEs/SAEs reporting |
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Medical coding |
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Qualified Clinical Sites |
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IPR protection, Multi-layered security environment |
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English speaking personnel for AE/SAE Reporting and Medical Writing |
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Strong IT skills for WebSys Electronic Data Capture (W-EDC), Data Management; Biostatistical analysis |
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Strong track record of clinical studies in pharmaceutical, biotech and medical devices |
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