Our client is a global pharmaceutical company with revenues of $ 4 billion and is the fifth largest specialty generic pharmaceutical company in the world, providing high-quality affordable medicines in over 150 countries. In the US market, which contributes a significant share of revenues, they are a leader in the generic dermatology and complex product segments.
Siebel is a state-of-the art system that meets all industry standards and regulatory requirements. However, Techsol determined that there were ways to enhance and accelerate the functionality of Siebel and developed AccelCTMS. After a complete study by the combined Client/Techsol team, including meetings with the organization’s key personnel for discussion and analysis, the Techsol staff identified critical issues for immediate action:
- Tools were needed to facilitate clinical trial planning with better budget development and resource allocation, protocol development, Investigator selection, subject eligibility and other associated tasks
- Site management and case management needed to be more effective by developing expeditious ways to track site visits, subject enrollment, study progress and payments to investigators and monitors
- Access to study data, internal and site operations and adherence to milestone achievement were not standardized and available to all users at all times
- Communication with CROs in many countries needed standardization with templates for complete and accurate critical information exchange and assured distribution to all study personnel involved
- Data integration across different EDC systems needed improvement
- Reports and communication required process improvement and standardization
- A quick and convenient method was needed to add customized add-on modules when needed
- There was costly, inadequate integration of data between clinical operations and business units
It was clear that the existing systems were state-of-the-art and met or exceeded all industry standards and regulatory requirements. However, the company needed additional tools to maximize the features and benefits of Siebel. Our recommendation was to build and install a customized version of AccelCTMS, fully integrated with and powered by Siebel Clinical. Techsol’s AccelCTMS accelerates clinical development by providing customized enablement tools including:
- Ability to collect and organize clinical trial information from all sources and provide cloud storage for all users real-time access
- Elimination of many manual procedures to automate, standardize and manage case work flow
- Preconfigured templates for off-the-shelf reports and standardized communications
- Multiple EDC systems compatibility and integration was lacking
- Flexibility to modify existing features and to add new modules
- Techsol performs implementation, validation of all elements, training and 24×7 technical support.
- The system is FDA Title 21 CFR Part 11 compliant and hosted on our fully managed, secure private cloud.
The client gained many favorable results by working with Techsol on the efficient implementation of CTMS:
- A high comfort level was achieved for all client end users and business associates
- The client participated in the development of the support plan and approved all terms and conditions
- The disaster recovery plan was developed to meet all Federal, State, and local laws and regulations