CTM Logistics

  • Receiving, storage, and distribution of clinical trials supplies
  • Obtaining of Import/Export Licenses from local Regulatory Authorities
  • Import of study drugs from Western Europe and USA
  • Export of biological media
  • Frozen and refrigerated batch shipments of biological specimens to laboratories in Europe, Canada, USA
  • Short to long-term specimen storage
  • Custom clearance (including pro-forma invoice creation and shipment documents review)

Data Management & Biostatistics

Biostatistics

  • Statistical consulting
  • Sample size estimation
  • Randomization
  • Analysis plans
  • Statistical analysis
  • Statistical writing
  • Presentation of results

Data Management

  • Data entry & verification
  • Data validation & query management
  • CRF & query tracking
  • Coding of diseases & medications
  • Import & export data
  • Presentation of results

Quality Assurance & Audits

  • Evaluation of Standard Operating Procedures and Study Specific Procedures for their consistency with International Quality Standards for designing, conducting, recording, and reporting clinical trials (ICH guidelines)
  • Assistance to Functional Managers in the development of Standard Operating Procedures
  • Approval of all Standard Operating Procedures and monitoring of the development, approval, periodic review, revision, version control, and historical archival of all Standard Operating Procedures
  • Conducting of Internal Audits to ensure that operation of all Functional Groups is in compliance with the internal Standard Operating Procedures
  • Overseeing external auditing or vendor qualification function (per Sponsor request)
  • Preparations for inspections by Sponsor and Regulatory Authorities
  • Representation of Sponsor in interactions with external organizations including Regulatory Authorities, Clinical Trial sites, and other organizations
  • Serving as a primary contact during all audits
  • Generation of responses to audit reports

Regulatory Affairs

  • Regulatory submission for approval of Department of Health
  • Regulatory submission for approval of Pharmacology Committee and National Ethics Committee
  • Obtaining of Import/Export Licenses
  • Expedited Study Approvals
  • Local Insurance policies for patients