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Clinical Trials Management (Phase II - IV):
With a strong presence in the niche area of conducting BA/BE studies for over half a decade, we, at Lambda, strategically expanded our business operations into Clinical Trials over a year back. This was done primarily to consolidate our business capabilities and give our clients a wide spectrum of
services.
We have the capability to carry out clinical trials Phase II – IV of your compound with unsurpassed precision, using our well trained Clinical Research Monitors, large patient data base and GCP trained Investigators in various therapeutic areas such as Oncology, Gastrointestinal, Cardiovascular, CNS, Respiratory, Autoimmune Deficiency, Analgesics/Inflammation and Anti-Infectives. All of this ultimately accelerates your drug development process. Data generated by us is wholly acceptable by global regulatory agencies worldwide.
Our team has successfully conducted over 18 multicentric phase II & III trials till date in the therapeutic areas of Gastrointestinal, Auto-Immune disorders, Oncology, Rheumatology, Dermatology, Respiratory disorders, Cardiovanscular, Central Nervous System, Analgesics/Inflamation and Anti-Infectives.
Our Clinical Trials Management cell has a committed team of professionals with a rich experience of handling multi-locational clinical trials. Our team is geared to meet the stringent requirements of both, the client and the regulatory bodies.
Our expertise in Phase II-IV studies
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Conducted over 18 Phase II & III studies so far |
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Designing and preparing study protocols, patient information sheet,
ICF |
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Designing Case Record
Forms/Patient Diaries |
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Hastening the site and investigator selection process based on their commitment and potential to comply with
protocols |
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Delivering robust results by monitoring every aspect of the study at each
site |
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Medical
monitoring & Medical writing |
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State-of-the-art
Clinical Trial Supply Facility (CTSF) |
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Data
management using ClinTrial® |
These study samples are analysed in our central
clinical laboratory located at Ahmedabad. The lab is accredited by the College of American Pathologists (CAP) in 2005. |