Clinical Trials

The management of a clinical trial has been highly complicated as various actors such as manufacturers, sponsors, ethical committees, regulatory authorities, trial centers, foundations, researchers, and participants intervene. In addition, it is necessary to work under the rules established by local and international regulatory bodies that ensure the quality of the study. Thus, companies need to work with a clinical research provider who is experienced, has the scale to deliver on time and within budget, and has a track record of successful trials and product approvals. 

We, as CRO with experience for management of clinical trials, provide support in population safety, efficacy, pharmacokinetics/ pharmacodynamics, exposure-response relationship, dose-finding in healthy volunteers, patients, pediatrics, and other special populations.

Some of the services we provide are listed below: 
  • Clinical trial design and development
  • Protocol development
  • Site selection and qualification
  • Medical monitoring
  • Safety monitoring / Pharmacovigilance
  • Regulatory support
  • Investigator meeting planning, production and execution
  • Investigational material packaging, labeling and distribution logistics (including IRT)
  • Electronic data management
  • Electronic trial master file
  • Site monitoring (on-site and central)
  • Biostatistics
  • Clinical study reports
  • Preparation of clinical submission documents
  • GCP audit and compliance services
  • Access to nationally recognized regulatory bodies