Clinical Operations

Clinigene's Clinical Operations team conducts Phase 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).

Services

Study Management

All projects are efficiently executed by qualified project managers who have experience conducting global Investigational New Drug (IND) studies. Our CRAs trained in ICH GCP guidelines and relevant national and international regulations oversee activities at study 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. We have conducted 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 relationship with study sites and work closely with each site to develop successful recruitment and retention strategies.

Site management also covers upgradation 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 Monitoring

Skilled 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.

CRAs add value to the conduct and timely execution of clinical projects. They travel to the study sites every four to six weeks or as per the sponsors’ requirements ensuring quality data, protocol adherence, compliance to regulatory guidelines and Standard Operating Procedures (SOPs). 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. 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 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 temperature 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, ensuring 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 the third parties. We have in place SOPs for vendor management which provides oversight on coordination structure and performance standards.