Project Management

Hanul provides a complete outsourced management solution for clinical trials projects.

The professionals at Hanul have worked in Phases I-IV and are committed to quality, time lines and economy. Clinical studies/trials are done as per in-house developed SOPs in accordance with ICH GCP guidelines and Indian GCP guidelines.

Hanul offers services in the following areas to help you maintain both your time lines and high quality standard.

Preclinical studies:

  • Review of protocols/ reports of Acute, sub-acute, chronic toxicity studies, efficacy studies and dose-schedule finding studies.

  • Monitoring of studies at approved animal laboratory.

  • Review and reporting of toxicological, preclinical data as per regulatory requirements.

Clinical trials:

  • Study Feasibility in consultation with investigators.

  • Selection of site, investigators.

  • Site Management.

  • Protocol planning and development in consultation with the investigators.

  • Designing of CRFs and other trial related (monitoring) documents.

  • Development of clinical trial protocol related statistical aspects (study design, sample size, statistical power determination) and analysis (interim/final) by biostatistician.

  • Training of investigators/staff for GCP guidelines and presentation of protocol at investigators meeting.

  • Custom designed visit and site-specific clinical trial materials.

  • Development of protocol-specific investigator instruction manuals and flow charts.

  • Regular monitoring visits to the sites to resolve queries related to data and reporting of AE/SAE

  • Timely submission of study status reports to the sponsor.

Phase I:

Hanul is experienced to set up phase I studies at contracted ICU in multispeciality hospital in compliance with GCP and GLP standards. It has:

  • Contracts with analytical facilities to conduct PK analysis

  • Specialized staff training at the phase I contracted site: investigators, physicians, pharmacologists, pharmaceutical scientists, nurses and analysts.

  • Prestudy and independent monitoring of BA/BE studies

Phase II & III:

Hanul offers end to end solution for conduction of Phase II & III trials.

  • Selection of sites most appropriate for the protocol.

  • Enrollment of investigators.

  • Efficient development and speedy initiation of the project.

  • Fast recruitment of the right patients .

  • Anticipate and resolve issues, problem during the run of the trial keeping the standards of quality high.

  • Ensure regulatory compliance with “schedule Y” of Drugs and Cosmetics act.

  • Cost efficiencies through tight controls

Phase IV / Post marketing surveillance:

Hanul has conducted post marketing surveillance in the following areas:

  • To satisfy regulatory requirements for a new labeling, advertising, efficacy or safety claim.

  • Clinical Experience Trials to widen exposure and usage of the product.

  • To support marketing claims and strengthen the product safety profile.

  • Collecting new data: Indication, dosage, population, safety profile for presentations and publications.

  • Extensive review of data and submission to regulatory agencies.