Medical writing services

At JCDC we also provide Medical writing services, Biostatistics services, Clinical Trial Monitoring and Project Management, Clinical Trial supply management, Quality Assurance At JCDC, we also have a team of professionals with experience in medical writing for trials across a wide array of therapeutic indications.

This includes authoring of clinical study documents

  • Antimicrobial and disinfectant testing including MICs and MBCs
  • Emerging Pathogens (MRSA, ESBLs etc)
  • Clinical Topical Antimicrobial Testing
  • Environmental Surveillance
  • Culture of anaerobes
  • Customized Microbiological Testing Services

Central Ethics Committee Review

For Non Regulatory studies, we offer Central ethics committee review services across Multiple sites.

Quality Assurance

Our independent quality control department conducts its own audits on an ongoing basis with a strong focus towards continuous improvement. At the same time, the focus of QA is on process efficiency and generating relevant management information to evaluate new improvement opportunities. We offer the following QA services

  • Investigator site audits
  • Sponsor / CRO audits
  • Vendor audits / assessments
  • Pre - Regulatory inspection audits
  • Medical and regulatory affairs audits
  • System audits
  • Standard Operating Procedure writing
  • Initial new employee training on ICH GCP, SOPs etc.

Biostatistics services

At JCDC, we have a dedicated biostatistics department with an eminent biostatistician of international repute heading the department. Our bio statistical services can be customized to your individual needs as we have a wide experience in the design and analysis of clinical trials ranging from parallel group, cross-over and Bayesian designs to complex (population) pharmacokinetic- and dynamic evaluations, therapeutic equivalence testing and large variable sample size.

Clinical Trial Monitoring and Project Management

We have a team of monitors and medical monitors with a strong grounding and base at the investigator site level making them highly experienced in addressing study specific and project needs. The team also assists in medical consulting and medical review of clinical study reports and Serious Adverse Events (SAE) processing.

Clinical Trial supply management

Our services include inventory management of clinical supplies. We have an ICH compliant storage and -80 Degrees refrigerators for serum samples / tissue blocks when required for long term preservation. We are involved in all aspects of overall drug accountability and destruction: from the site initiation to study close out of a clinical trial.

  • For any further queries or questions,
    please feel free to contact us