• Latest Clinical Trial Trends In India
  The year 2011 was considered as a “roller coaster” wide by many medical experts in the Indian clinical trial industry. Clinically the enthusiasm that has set in with India is attaining importance in the global biopharmaceutical environment.
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• Nearly 500 ethics committees registered after CDSCO made it mandatory in Feb, 2013
  Evoking a very good response to the steps by the regulatory authorities to streamline the clinical trials sector, nearly 500 ethics committees of hospitals and clinical trial organisations have secured registration within just five months after it was made mandatory
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• Open Innovation for Public Welfare Initiatives
  The urge to do introduce something unique and contribute to the society has made most enterprise’s resort to idea management techniques. In the recent past, for a new product development or a product revamp strategy, enterprises are communicating with the consumer and audience at large for their ideas and feedback.
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• Phase I Clinical Trial
  Phase I clinical trial : Lotus Labs leadership & a proven track record in the effective conduct of Phase I Clinical Trial is reflected in the fact that we have a strategic working relationships with reputed hospitals that ensures having access to a large database spanning diverse therapeutic areas.Lotus Labs has extensive capabilities to conduct Phase I Studies in healthy volunteers which include studies First-in-Man, Single ascending dose, multiple ascending dose and new chemical entities.
  in Public bookmarks with 1 clinical i phase phase-i-clinical-trial trial trials by 3 users
• Phase I Clinical Trial
  Phase I clinical trial : Lotus Labs leadership & a proven track record in the effective conduct of Phase I Clinical Trial is reflected in the fact that we have a strategic working relationships with reputed hospitals that ensures having access to a large database spanning diverse therapeutic areas.Lotus Labs has extensive capabilities to conduct Phase I Studies in healthy volunteers which include studies First-in-Man, Single ascending dose, multiple ascending dose and new chemical entities
  in Public bookmarks with 1 clinical clinical-trials-phase--1 i phase trial trials by 2 users
• Phase I Clinical Trial
  Phase I clinical trial : Lotus Labs leadership & a proven track record in the effective conduct of Phase I Clinical Trial is reflected in the fact that we have a strategic working relationships with reputed hospitals that ensures having access to a large database spanning diverse therapeutic areas.Lotus Labs has extensive capabilities to conduct Phase I Studies in healthy volunteers which include studies First-in-Man, Single ascending dose, multiple ascending dose and new chemical entities.
  in Public bookmarks with 1 clinical i phase trial trials by 3 users
• State-of-the-Art Phase I Clinical Trial Facilities
  Lotus Labs has independent Phase I clinical trial facility & the expertise to conduct First-In-Human Studies, Pharmacokinetic studies, Bio-availability & Bio-equivalence studies, Drug Metabolism studies, Dose Proportionality & Multiple dose studies & more.
  in Public bookmarks with 1 clinical i phase trial trials by 3 users
• State-of-the-Art Phase I Clinical Trial Facilities
  Lotus Labs has independent Phase I clinical trial facility & the expertise to conduct First-In-Human Studies, Pharmacokinetic studies, Bio-availability & Bio-equivalence studies, Drug Metabolism studies, Dose Proportionality & Multiple dose studies & more.
  in Public bookmarks with 1 clinical i phase phase-i-clinical--trial trial trials by 2 users
• Try Array Risk-Free Today
  Try Array Risk-Free Today! 30-day free trial of Array’s software load balancing, secure access and WAN optimization products for cloud and virtual environments.
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• US FDA issues norms on delaying a drug inspection,waits industry comments
  "The US FDA has issued guidance to the pharma industry on circumstances that constitute delaying, denying, limiting, or refusing a drug inspection. The regulatory major is seeking industry comments to this effect by September 30, 2013. "
  in Public bookmarks with clinical organization research services trial trials by 2 users
• US FDA issues rules on Electronic Source Data in Clinical Investigations;Indian CROs view it platform to prove proofs
  US Food and Drug Administration (FDA) has issued the guidance for industry on Electronic Source Data in Clinical Investigations. This guidance provides recommendations to sponsors, Contract Research Organisations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.
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• US FDA norms for clinical investigators, sponsors & to ascertain need for human studies for IND
  "In a major development on the regulatory landscape for clinical trials, the US Food and Drug Administration (FDA) has now issued a guidance which is intended to assist clinical investigators, sponsors, sponsor-investigators and institutional review boards (IRBs)."
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• US FDA seeks industrys comments on new draft norms on ANDA submissions
  The US FDA has sought the pharma industry's comments on its draft guidelines on ANDA (abbreviated new drug application) submissions ― Refuse-to-Receive Standards.
  in Public bookmarks with clinical organization research services trial trials
• US FDA to reduce backlog of generic drug applications, increase inspections
  With US Food and Drug Administration (FDA) planning to work towards reducing the backlog of generic drug applications under the Generic Drug User Fee Act (GDUFA), Indian pharmaceutical companies have however cited challenges like approval time for abbreviated new drug applications (ANDAs)– the applications filed for generic drugs and heightened inspection activities, as GDUFA requires stepping up number of foreign inspections.
  in Public bookmarks with clinical organization research services trial trials

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