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Clinical Trial Services Provided by CTU

We offer comprehensive clinical trial services in support of Phase II and III studies, which provide the basis for regulatory approval of new pharmaceuticals and medical devices.

We also support phase IV studies to explore new indications, to enable early clinical experience, to evaluate treatment effectiveness in everyday clinical setting and post-marketing pharmacovigilance.

Our core clinical trial services include the following:

Research Grants

CRC is allocated a yearly research grant by the Deputy Director General Office (Research & Technical Support) for this IIT program.

Compliance

Practical assistance and subsidies to comply with GCP, NIH research guideline and applicable regulations

  • Trial registration
  • Ethics and regulatory authority submission
  • Trial insurance
  • Professional indemnity
  • Contract administration (for IIT funded by external third party)

Trial services

A range of professional clinical trial services:

  • Trial design and protocol development
  • PIS/ICF development
  • Study initiation, monitoring and closeout
  • IVRS central randomization
  • Data management
  • Pharmacovigilance
  • Biostatistics

Medical Writing

CRC provides assistance in writing manuscripts deemed for submitting to reputable international journals.
CRC probably publishes more clinical trial publications than any other Malaysian research institutions

Education & Training

Good Clinical Practice Training and Certification
Conduct research training courses particularly for clinical trial:

  • Clinical Trial Design and Protocol Development
  • Clinical Research Ethics
  • Clinical Project Management
  • Clinical Trial Management
  • Medical Scientific Writing

Investigator Initiated Clinical Trial Brochure