Clinical Trial Management
Clinical Trial Services: Management, Monitoring & Supply
Syngene's clinical operations team conducts phases I-IV clinical trials and patient based BE studies for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. Our team of well-trained professionals has a collective experience of over 150 years in project management across 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 provide quality monitoring services in compliance with the applicable regulatory guidelines, we conduct comprehensive training and development programs for our Clinical Research Associates (CRAs).
We offer the following clinical trial management services:
All projects are efficiently handled by qualified project managers experienced in various therapeutic areas including oncology, endocrinology, gastroenterology, cardiovascular, dermatology, infectious diseases, neurology, immunology, orthopedics, respiratory, and metabolic disorders. We have extensive experience in Community based clinical studies and Observational studies.
Our project managers are single point of contact for sponsors. Project managers are responsible for timely execution of the study ensuring highest quality deliverables within the allocated budget. During the conduct of the study, project managers works closely with Medical Writers/Monitors, Regulatory team, Clinical Monitors, CDM team & Biostatisticians for seamless conduct of study activities.
Our project managers are experienced in working with Project Management tools such as Enterprise Project Management (EPM) to effectively track the progress of the project and mitigate potential risks.
Our project management team has successfully organized many investigators’ meetings, both in India and abroad.
Syngene has dedicated site feasibility team for conducting site feasibility & validation as part of study start up activity.
After a thorough feasibility assessment our team tailors recruitment and retention plans unique to each site. Focusing on the site's strengths and experience. We have well-established relationships with hundreds of study sites across India 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 continually identify new investigators and train them to enrich the investigator database across different therapeutic areas. Our team also handles site finance management.
Clinical Trial Monitoring
Syngene’s Clinical Trial Monitors(CTMs), with a background in life sciences or medicine, are the main strength of the clinical operations department and add value for the timely execution of clinical projects. They have strong organizational skills, eye for detail, good written and oral communication skills and 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 to ensure quality of data, protocol adherence and compliance with regulatory guidelines. CTMs undertake regular follow-up visits to study sites and provide weekly updates to both Clinical Project Managers and sponsor as needed. They also monitor drug dispensing procedures and drug accountability, conduct source data verification, data collection, safety reporting, informed consent form review and resolve data queries.
The team has a working knowledge of 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).
Clinical Trial Supply Management
Syngene provides end-to-end management of clinical and ancillary supplies. We have extensive expertise in handling IRT modules like IVRS and IWRS. Our team develops a customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to SOPs of Syngene/Sponsor and regulatory guidelines. 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 and an enterprise resource program (ERP) to manage the inventories of all supplies.
Our facility has a separate 700 sq. ft. access-controlled, clinical supplies unit that maintains temperatures between -15 to -25°C, 15 to 25°C and 2 to 8°C. This unit has an electronic temperature monitoring system along with an auto alarm system.
To prevent degradation of clinical trial supplies, Syngene partners with reliable cold chain logistics solution providers to ship supplies in stable refrigerated conditions to the investigational sites.
Syngene also provides vendor coordination and management as a key service based on sponsor requirements. Our clinical operations project managers serve as the single point of contact assuring uninterrupted communication and coordination with third parties.
We have established SOPs for coordinating with vendors and to monitor performance standards. Our Project Managers have set up complex logistics for Clinical studies by expert coordination with Vendors, which includes.
- Translation Services
- EDC/RDC Providers
- IVRS Systems
- IWRS Systems
- Central Lab Services
- Imaging Labs
- Specialized diagnostic providers