Enabling effective clinical research through comprehensive clinical trial management services
Syngene’s clinical operations teams provide comprehensive clinical trial management services to conduct phase I to phase IV clinical trials and patient-based bioequivalence (BE) studies. We maintain the highest standards of quality, ethics, and confidentiality for our clients that include several reputed biotech and pharmaceutical firms. With over 150 years of collective project management experience, our well-trained professionals who are experienced in several therapeutic areas help us successfully handle audits from international clients and independent auditors.
Syngene promotes a team-based work approach with an emphasis on management, recognition, training, support, accountability, and personal development. We also conduct a wide range of training and development programs for our clinical research associates (CRAs), enabling us to comply with applicable regulatory guidelines for quality monitoring services.
Our project managers have extensive experience in community-based clinical studies and observational studies, as well as in various therapeutic areas such as oncology, endocrinology, gastroenterology, cardiovascular, dermatology, infectious diseases, neurology, immunology, orthopedics, respiratory, and metabolic disorders.
As single points of contact for sponsors, our project managers handle timely execution of studies and ensure deliverables of the highest quality within the allocated budget. The project managers seamlessly conduct studies by working closely with medical writers/ monitors, regulatory teams, clinical monitors, clinical data management (CDM) teams, and biostatisticians. We use project management tools such as enterprise project management (EPM) to track the progress of projects and mitigate potential risks. Our team has also successfully organized many investigator meetings for clinical trials, both in India and overseas.
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.
Syngene’s dedicated site feasibility team conducts feasibility and validation studies as part of the start-up activity and is also responsible for managing finances. Our well-established relationships with a large number of study sites across India help us perform thorough feasibility assessments and develop unique strategies for recruitment and retention based on a site’s experience and strengths. We constantly identify and train new investigators, enriching our database of investigators across therapeutic areas, and upgrading site infrastructure to meet the requirements for clinical trials.
Clinical trial monitoring
With a background in life sciences or medicine, our clinical trial monitors (CTMs) are the backbone of the clinical operations department, adding value towards timely project execution. Our CTMs have strong administrative skills, an eye for detail, and excellent oral and written communication skills. They are also trained in the good clinical practices (GCP) guidelines of the International Conference on Harmonization (ICH) as well as other national and international regulations.
The CTMs visit study sites at four-to-six-week intervals or as per the sponsor’s standard operating procedures (SOP) for trial monitoring. They ensure the quality of data, adherence to protocols, compliance with regulatory guidelines, and provide weekly updates to both clinical project managers and sponsors as needed. Their duties also include monitoring drug dispensing procedures and handling drug accountability, conducting source data verification, collecting data, performing safety reporting, reviewing informed consent forms, and resolving data queries.
The team has a working knowledge of systems such as 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 supports clients with turnkey solutions for the management of clinical and ancillary supplies, including assistance with obtaining import licenses, customs clearances of clinical supplies and drug destruction. Our dedicated pharmacists are accountable for clinical trial supplies, including storage and handling, and maintain an inventory with an enterprise resource program (ERP) system. We help develop customized logistics models for unique sponsor requirements while following Syngene/ sponsor’s SOPs and regulatory guidelines. We have extensive experience in handling interactive response technology (IRT) modules such as IVRS and IWRS.
Syngene provides vendor management and coordination as a key service, based on sponsor requirements. Our clinical operations project managers use established SOPs to coordinate with vendors, monitor performance standards, and provide uninterrupted communication. Serving as single points of contact, they expertly coordinate with various vendors across translation service and electronic data capture/ remote data capture (EDC/RDC) providers, IVRS and IWRS systems, central lab services, imaging labs, and specialized diagnostic providers.
Our facility includes a 700 square feet access-controlled clinical supplies unit that maintains temperatures between -15 to -25°C, 15 to 20°C, and 2 to 8°C. The clinical supplies unit also 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 investigation sites.
Our team uses ‘Syng Connect’, a secure project specific portal to share, exchange, and archive vital documents quickly. The portal is equipped with version control tools to help track changes made by different team members during live projects. The portal helps project teams to collaborate and share documents in real time, reducing the need to physically travel to the office.