Clinical Operations

Clinigene's Clinical Operations team conducts Phases I-IV clinical trials for the world’s best drug discovery and development companies, maintaining the highest standards of ethics, quality and confidentiality. Our team of well-trained professionals has a collective experience of over ten decades in project management in various therapeutic areas. This extensive experience has also helped us to successfully handle audits by our international clients as well as independent auditors.

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

Project Management
Site Management
Clinical Trial Monitoring
Clinical Trial Supply Management
Vendor Management

Project Management

All projects are efficiently handled by qualified project managers who are experienced in various therapeutic areas, like Oncology, Endocrinology, Gastroenterology, Cardiovascular, Dermatology, Infectious diseases, Neurology, Immunology, Orthopedics, Respiratory and Metabolic disorders.

Our project managers act as a single point of contact for Sponsors throughout the duration of the study, ensuring quality deliverables within the timelines and budget. They oversee every aspect of the clinical trial management and handle issues as and when they arise. Protocol-related queries and safety/clinical concerns are addressed through close collaboration of the project managers and medical monitors, ensuring the integrity of clinical trial data.

Our project managers have adopted project management tools like Enterprise Project Management (EPM) to effectively track the progress of the project and handle potential issues proactively.

Our project management team has successfully organized many investigators’ meetings, both in India and abroad.

Site Management

The Clinical Operations team selects each study site based on the site infrastructure and access to appropriate patient population. A recruitment and retention plan unique to each site is prepared, focusing on the site's strengths and experience. We have well-established relationships with study sites and work closely with each site to develop successful recruitment and retention strategies.

Site management also covers up gradation of site infrastructure to meet clinical trial requirements. We continuously identify new investigators and train them to enrich the investigator database across different therapeutic areas. Site finance management is also handled by our team.

Clinical Trial Monitoring

CRAs add value to the conduct and timely execution of clinical projects. Clinigene’s CRAs with Life Sciences and Medical background are the main strength of the Clinical Operations department. They have strong organizational skills, eye for detail, good written and oral communication skills. Our CRA’s are trained in the ICH GCP guidelines and relevant national and international regulations. They travel to the study sites every four to six weeks or as per the sponsors’ monitoring SOP ensuring quality data, protocol adherence and compliance to regulatory guidelines. Regular telephonic follow-up with study sites and weekly status updates to the sponsor are 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 review and resolving data queries.

The team has working knowledge in handling e-systems like Enterprise Project Management (EPM), Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems (IVRS) and Interactive Web Response Systems (IWRS).

We also have an e-Document Management System providing significant leverage in handling disaster recovery and business continuity. All the scanned study specific documents are saved in ViewWise™ and the server is maintained at a secure external facility. The server room, archival and clinical supplies unit are equipped with a fire suppression system. Based on the client request, we provide remote read access to the respective study documents.

Clinical Trial Supply Management

Clinigene provides end-to-end management of clinical and ancillary supplies. Our team develops a 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 clinical supplies. Depending on the requirements of the sponsor, we also take the responsibility of drug destruction. We have dedicated pharmacists responsible for storage, handling, and accountability of clinical trial supplies.

Our facility has a separate 700 sq ft access controlled, clinical supplies unit that maintains temperatures between 15-20°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 reliable courier agencies for the distribution of drugs to investigator sites. Temperature loggers are used during shipment, to ensure proper temperature control and record maintenance.

Vendor Management

Based on the Sponsor requirements, Clinigene also provides Vendor coordination and management as a key service. Our Clinical Operations project managers serve as the single point of contact assuring uninterrupted communication and coordination with third parties. We have in place SOPs for vendor management which provides oversight on coordination, structure and performance standards.