CTM Logistics

Our CTM Logistics Service includes the following:

  • 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