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2. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...

3. Electronic trial master file - Wikipedia

   en.wikipedia.org/wiki/Electronic_trial_master_file

   An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

4. List of Guidances for Statistics in Regulatory Affairs

   en.wikipedia.org/wiki/List_of_Guidances_for...

   FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.

5. ePharmaSolutions - Wikipedia

   en.wikipedia.org/wiki/EPharmaSolutions

   ePS was founded in 2001 by Lance Converse and is headquartered in Plymouth Meeting, Pennsylvania, employing 60+ clinical researchers and technologists. ePharmaSolutions' Clinical Trial Portal technology won the 2009 and 2013 Bio-IT World for “Best in Class Clinical Trial Technology” and the 2013 Microsoft Lifesciences Innovation Award ...

6. Good Clinical Practice Directive - Wikipedia

   en.wikipedia.org/wiki/Good_Clinical_Practice...

   The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

7. List of clinical trial registries - Wikipedia

   en.wikipedia.org/wiki/List_of_clinical_trial...

   The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]