Clinical Operations

Clinigene’s Clinical Operations department has a team of well trained professionals with global Investigational New Drug (IND) studies exposure. Our collective team experience spans over two decades in project management of the various therapeutic areas. Our reputation for conducting clinical trials (Phase I-IV) that maintain the highest standards of ethics, quality and confidentiality continues to attract the world’s best drug discovery and development companies.

We promote a team approach with an emphasis on management, support, recognition, training, accountability and personal development. To ensure our clients receive quality monitoring services, we provide our Clinical Research Associates (CRAs) with a comprehensive training and development program to ensure compliance with applicable national and international regulatory requirements and guidelines.

Study Management

All projects are efficiently executed by project managers who have rich experience in conducting international standard studies. Qualified and experienced CRAs trained in ICH GCP guidelines and relevant national and international regulations oversee activities at trial sites.

This structure combined with a proactive plan for issue identification and resolution provides a flexible and responsive approach for successful clinical trial completion within specified timelines. Protocol-related questions and other safety or clinical concerns are addressed through the close collaboration of project managers and medical monitors, ensuring the integrity of clinical trial data. The team is also well experienced in conducting investigators’ meetings.

Site Management

The Clinical Operations team selects each clinical site based on access to appropriate patient population. A recruitment and retention plan unique to each site is prepared, focusing on the site's strengths and past successes. The team has well-established relationships with clinical sites and works closely with each site to develop successful recruitment and retention strategies.

Site management also covers upgradation of site infrastructure to meet clinical trial requirements. Clinigene is continuously developing new investigators and training them to enrich the investigator database in different therapeutic areas.

Site finance management is also a core activity of the Clinical Operations department.

Clinical Monitoring

Multi-skilled CRAs with medicine, pharmacy, biotechnology and other life sciences background trained in ICH GCP, local and international regulations are the main strength of the Clinical Operations department. They have strong organizational skills and an eye for detail. They work well in a team and have good written and oral communication skills.

CRAs play a very important role in the coordination between the clinical trial sites and the sponsor as this ensures completion of the study within specified timelines.

The CRAs are responsible for start-up and initiation of study at selected sites. They travel to all the clinical trial sites once every four to six weeks or as per the sponsors’ requirements ensuring quality data, compliance to local and international regulatory guidelines and protocol adherence. Regular telephonic follow-up with the sites and weekly status updates to the sponsor is systematically conducted by every CRA. They also monitor drug dispensing procedures and drug accountability. Other tasks include source data verification, data collection, safety reporting, informed consent form reviews and resolving data queries.

The team has working knowledge in the use of e-systems like EDC, CTMS, IVRS and IWRS.

Clinical Trial Supply Management

Clinigene is capable of providing end-to-end management of clinical trial supplies. The clinical trial supply management team is equipped with a full range of logistics services to manage, store and distribute clinical trial supplies. The team develops customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to SOPs of Clinigene/sponsor and regulatory guidelines.

Our project management expertise, backed by supporting technologies provides a deeper insight into the supply needs for each protocol.

Our service begins with providing assistance in obtaining import license and custom clearance of drug supplies. Depending on the requirements of the sponsor, we also take the responsibility of drug destruction.

We have dedicated pharmacist responsible for storage, handling, and accountability of clinical trial supplies.

Our facility has a separate access controlled clinical supplies unit that maintains ambient temperature (25 ± 5°C) and 2-8°C. This unit has an electronic temperature monitoring system along with an auto alarm system.

Cold chain shipment is provided using dedicated and experienced courier agencies for the distribution of drugs to investigator sites. Temperature loggers are used during shipment, ensuring proper temperature control and record maintenance.