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In recent years, there has been a steady decrease in the number of NCEs for regulatory approvals due to high attrition rate in various phases of drug development. To bridge the gap between cost and time there is a need for alternative approaches such as PK / PD modeling and simulation (M&S).

  • Predictive modeling tools provide invaluable information to better streamline the drug development process
  • Modeling approaches prove useful in determining relationships between biomarker responses, drug levels and dosing regimens of new drugs, faster and at a lower cost

Optimal use of M&S will lead to fewer failed compounds in late stage development, fewer study failures and smaller number of studies needed to support the registration.

GVK Biosciences (GVK BIO), Asia's leading Contract Research Organization, delivers customized data curation services to the life sciences industry. GVK BIO's scientists analyze data to transform biological patterns into knowledge.

  • Building and maintaining indication specific clinical trial outcome databases for use in M&S efforts
  • Rich experience across therapeutic areas (> 50 indications covered)
  • High quality deliverables and adherence to timelines
  • Manual curation by qualified scientists

Characteristics of the data fields

  • Literature source information
  • Study design information
  • Demographic information
  • Treatment information
  • Pharmacodynamic information
  • Pharmacokinetic information

Key Features

  • Client defined specifications and literature
  • Rigorous QC to ensure high quality
  • Protection of Intellectual Property
  • Updates on a regular basis
  • Well defined process
  • Client defined data formats

Literature Sources

  • Journal publications
  • Clinical trial registries
  • Conference posters
  • Regulatory reviews
  • Proprietary data
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