Clinical trial management system (CTMS)
Clinical trials are complex and time consuming. There are too many activities to be performed. The activities are diverse in nature and interdependent. Clinical trials are the single most expensive component of the entire product development process. The Clinical Trials Management System (CTMS) designed and developed by SPRIM ADVANCED LIFE SCIENCES is a centralised system that caters to operational and administrative activities of Clinical trials.
These are resource-intensive areas and often involve repetitive, manual processes for collecting, aggregating and rationalising information from a wide variety of data sources. It is difficult for CROs, nutraceutical companies and medical device companies to organise and manage the large workforce required, as well as medical appliances and other resources.
The CTMS with its set of modules intelligently caters to this complex need. Information islands generated by different appliances have to be collated, and CTMS makes this possible through data migration modules. This allows sponsoring organisations to proactively manage their trials by appropriately streamlining processes while comparing different platforms. Hence, CTMS helps to improve operational efficiency and bring down overall time and cost requirements.
“We believe in technology support as an indispensable tool
for directly reaching subjects involved in a research program, improve benefit
around the world with connected solutions.”
Server house and data center
The data collection process must be supported by a secure data management and storage system. Our research projects are based on encrypted servers located in dedicated data centres on our biometric hub. We can rely on a primary data centre and on a second server for daily backups, storage and disaster recovery. Specialised staff and experts are called upon during the pre-production phases, during the study’s execution, to develop and test custom-made data storage solutions that can support the post-production phase – from raw data collection to final custom data transfer.
Lear how our server services can support your study:
- Support resource sharing across studies in a secure manner;
- Manage longitudinal data for complex and recurring patient visits;
- Automated and manual capabilities for import, export, and data interchange with other systems;
- Rule engine performing advanced validation of study data and define automated actions within the system;
- Enable compliance with Good Clinical Practice (GCP) and regulatory guidelines, such as 21 CFR Part 11, via differentiated user roles and privileges, password and user authentication security;
- Electronic signatures, SSL encryption, de-identification of Protected Health Information (PHI), and comprehensive auditing to record and monitor access and data changes.