Our Innovative Approaches
Our extensive database of Principal Investigators, leading hospitals, and research centres allows us to access special populations to fulfil your protocol requirements and ensure rapid recruitment of eligible study subjects.
For Clinical Trials in India, we offer site management services, project management, and patient recruitment strategies. Along with our innovative approaches, creative problem-solving, and dedicated professionals, HRAPLs’ transparency in operations is a key factor in building quality and trust with our clients. Our robust information delivery system allows us to provide clients with on-demand access to critical data.
Meet Our Team
Dr. Pradnya Anil Mahatme is the dynamic leader in charge of Clinical Operations at Hector Research and Archival Pvt. Ltd. (HRAPL) an emergent Site Management Organization (SMO) in India. Before this, she played an instrumental role as the Head of the Start-up department at GDD Experts, a US-based SMO, where she also took on the roles of Project Manager and Director. Dr. Pradnya boasts an impressive educational background, holding a Doctoral Degree in Clinical Biochemistry and a Diploma in Clinical Research. With over 16 years of professional experience in the field of Clinical Research, she possesses a profound knowledge of Clinical Biochemistry in relation to the conditions under investigation. Her leadership transcends professional boundaries, as she serves as a mentor, guiding the next generation of clinical researchers, and as an inspirational figure, driving excellence among her peers. Dr. Pradnya’s profound influence extends throughout the tapestry of clinical research in India, where she stands as a luminary, shaping the landscape with her dedication to advancing medical science.
Project Management Team
- Highly experienced and responsive.
- Impeccable track record for delivery on time and with quality.
- 5-25 years’ experience in the pharmaceutical industry, including long-term cohesiveness of the management team.
- Experience with all phases of clinical trials (Phase I -IV) across multiple therapeutic areas, in both paper and EDC environments.
HRAPL Advantages
- Rapid enrolment.
- Quick query resolution.
- Expedited site initiations.
- Expedited Timelines based.
- Efficient on-site monitoring.
- Speed of Execution: Flat structure and global locations, allows around-the-clock execution of priority activities.
- Flexibility: Ability to adapt internal processes to ensure timely execution of sponsor’s requirements.
- Financial Advantage: Project-specific efficiencies significantly reduce overall budgets.
- Key Therapeutic Area Knowledge and expertise via strong training programs.
- Quality: Activities conform to DCG(I), EMA, FDA requirements.
- Data entry: Highly experienced and responsive team with experience across all study phases, offering high quality and timely EDC entry ensures cost-effective management.
Cumulative years of experience
No. of Studies
No. of Audit and Inspections
Frequently Asked Questions
WHAT IS THE MAIN PURPOSE OF CONDUCTING CLINICAL TRIALS?
Many clinical trials are conducted to determine whether a new drug or device is safe and effective for people to use. Clinical trials are also conducted for other purposes. Some compare existing treatments to identify which is more effective. The currently approved treatments are referred to as “standard treatments.” In some cases, clinical trials are used to explore different ways to utilize standard treatments to make them more effective, easier to use, and/or reduce side effects. Additionally, some studies are conducted to determine how to best use a treatment in a different population, such as children, where the treatment has not been previously tested.
WHERE CAN PEOPLE FIND OUT ABOUT CLINICAL TRIALS?
People can find information about ongoing clinical trials through various resources. Globally, ClinicalTrials.gov, an interactive online database managed by the U.S. National Library of Medicine, provides details on both federally and privately supported clinical research involving human volunteers. It is regularly updated and includes information about each trial’s purpose, eligibility criteria, locations, and contact details for further inquiries.
In India, clinical trial information is available on the Clinical Trials Registry – India (CTRI). Managed by the Indian Council of Medical Research (ICMR), CTRI is a public online database that offers comprehensive details about clinical trials conducted within the country. It provides information on trial objectives, eligibility criteria, study sites, and investigator contact details, ensuring transparency and accessibility for stakeholders.