Clinical Trial Management
Clinical Trial Services: Management, Monitoring & Supply
Syngene's clinical operations team conducts phases I-IV clinical trials 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 act as a single point of contact for sponsors throughout the duration of the study, ensuring quality deliverables within the timelines and budget. Project managers collaborate closely with medical monitors to address protocol-related queries and safety/clinical concerns thereby ensuring the integrity of clinical trial data. Project Managers also coordinate with Regulatory, CDM and Biometrics teams regarding regulatory approvals, Data cleaning/DB lock, Statistical Analysis and CSR.
Our project managers have adopted project management tools such as 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.
Clinical Operations includes a dedicated Site feasibility team to perform pre sales feasibility and Site validation as part of study start up activity. Clinical operations team selects each study site based on the infrastructure and access to appropriate patient population. Syngene has a robust and extensive database of investigational sites which is developed by conducting detailed study feasibility assessment capable of identifying qualified Investigators and investigational sites with high degree of quality. Our database also provides information on the projected patient enrollment rates, competing clinical trials at the site, site personnel experience and training, site infrastructure, local IRB/IEC requirements and timelines.
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 CRAs, 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. CRAs 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