You are currently browsing the PLS Clinical Research Blog weblog archives for November, 2009.
- Uncategorized (21)
- 22. March 2010: Informed Cosent
- 22. February 2010: Data Capture Methods
- 8. February 2010: Costs and finances in clinical trials
- 27. January 2010: Clinical Trials: Need and Ways
- 25. January 2010: PROJECT MANAGEMENT
- 17. January 2010: Pharmacovigilance :
- 17. January 2010: Adaptive Clinical Trials
- 11. January 2010: How ICH-GCP differs from Indian GCP?
- 25. December 2009: An exclusive workshop on fundamentals of ICH-GCP and clinical research
- 17. December 2009: Top 5 Mistakes of RFP
Archive for November 2009
“Single-window” and e-governance
30. November 2009 by harshit.
The most recent initiative announced by the CDSCO is possibly one of the most exciting. The Ministry of Health and Family Welfare has agreed to invest close to INR250 Crore (around $50 million) in an e-governance initiative for the CDSCO to operate efficiently and transparently. Some of the e-governance initiatives contemplated include online submission of all forms, a digitalized interactive portal, digitalization of records and online approvals with digital sign. Currently, six Indian government departments have some role in approving certain aspects of drug regulations, a situation that leads to delays and a waste of resources. US-based technology solutions provider MGRM is developing a system to track and manage the complete drug regulation process. By 2013 companies are expected to be able to file and track applications online and access information concerning licensing, regulation, monitoring and even inspection audits13. Initiatives such as the central registry of volunteer fingerprints and another recently launched initiative of releasing on a daily basis, correspondence concerning drug and device companies would be accessible via the system. Internal to the CDSCO, the technology is expected smooth the interface between relevant government departments.
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Welcome to Progressive Life Sciences, a full service CRO including Bioavailability, Bioequivalence Clinical Studies.
25. November 2009 by harshit.
It is a professional team where innovative solutions, strategies, logistics speed the early stage clinical development. Accuracy, reliability, expertise, experience and excellence characterize our delighted and committed Experts contributing to advance medical research for healthier living. Our clinical trial management services include regulatory affairs, project management, medical writing, data management, site management, safety & quality monitoring for phase I, II, III & IV trials, and bioequivalence trials At PLS every customer matters and each project is unique. Our deep knowledge of local regulatory requirement and our extensive experience with studies clinical conduct allow us to gauge how trial protocols manifest in real-life. Sponsors can therefore plan and budget based on accurate projections, they can meet their own deadlines and goals.In the complicated process of drug development, approximately 70% of the costs are incurred in clinical testing. We help our clients achieve significant cost savings and help reduce their time to market by helping them outsource their trials to India. We believe PLS offers the following edge to our global customers by operating in India. We conducted clinical studies in the following therapeutic areas but not limited to: Psychiatry and neuropsychiatry, Medical Oncology and Hematology, Medical Device study and Neurology. PLS offers a variety of clinical studies driven by Ethics, ICH-GCP guidelines, Quality and speed
-Phase I to Phase IV clinical trials
-BA/BE studies
Should you require any information, we’ll be pleased to assisting you: call +91-9873512366 or write to info@progressivelifesciences.com
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What are PROTOCOL DEVIATIONS, EXCEPTIONS AND VIOLATIONS?
23. November 2009 by prakash Mathew.
Protocol when goes haywire its what????
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Hello world!
19. November 2009 by admin.
Welcome to WordPress. This is your first post. Edit or delete it, then start blogging!
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