Drug Development is a very competitive global environment and there is considerable pressure on most organisations to make their operational processes more efficient and effective. Pharmaceutical companies, biotechs and CROs are asking for innovative tools that are cost-effective, intuitive, easy-to-use and compliant to regulatory requirements.
The implementation of a new Clinical Data Management System (CDMS) / Electronic Data Capture (EDC) tool within an organization is an important milestone as it involves different aspects such as financial, resources, processes and regulatory.
In the last couple of years CROS NT has implemented two new EDC systems, namely Symphony and RAVE. RAVE EDC accreditation was recently completed together with the implementation of additional modules such as Coder and Balance.
Both systems are SaaS (Software as a Service), this is a software distribution model in which a third-party provider hosts applications and makes them available to customers over the Internet. SaaS removes the need for organizations to install and run applications on their own computers or in their own data centers. This eliminates the expense of hardware acquisition, provisioning and maintenance, as well as software licensing, installation and support.
To implement a new system within the organization, the Business Process Owner will prepare an implementation plan to describe activities, resources, timelines and budget required to complete the implementation.
The first step when implementing a new system is to identify the key members of the implementation team. These should include (as a minimum):
- Functional members (‘Expert team” i.e. Data Managers, Database Programmers)
- Business Process Owner
- Quality Assurance
- Computer System Validation (CSV)
- Information Technology (IT)
Once the implementation plan is approved and the implementation team identified, the Business Process Owner (BPO) will liaise with the relevant parties to start the implementation.
The first step is to identify training requirements and develop a Training Curriculum that will be specific to the user role. Examples of such role-specific training are:
- Database Programmers: how to build the e-CRF, how to program data checks, how to manage mid-study changes, how to manage data extraction and report, how to manage user accounts/user access, how to manage user training.
- Data Manager: how to manage queries, how to code medical terms, how to run reports, how to freeze and lock a database.
- Statistical Programmer: how data is exported, their format, the content etc.
Once all required training is completed, the next step is to build a mock study to implement all the training learnings and see if training was effective or there are any areas to clarify with the trainer.
In parallel the BPO will start developing Standard Operating Procedures (SOPs) and Work Instructions (WIs) to cover all the processes that will be applied in the system, such as how to build a study, how to validate the study, how to program edit checks, how to validate edit checks, how to make mid-study changes, how to clean data etc.
SOPs and WIs will follow the company standard cycle of internal reviews by technical experts to ensure the process contained within the document is accurate and complete and is compliant with respect to regulatory requirements.
When SOPs and/or WIs are in their final draft version, the next step is to perform validation tasks. Validation involves different tasks : Risk Assessment, Compliance Assessment, Validation Plan, Business Requirements, Performance Qualification Protocol and Validation Report.
The purpose of validation is to ensure that the system can be implemented within the organization in compliance with company standards and processes and that the system fulfils the organizational and operational needs. The BPO, QA, IT and CSV Manager will evaluate the possible risks related to the system implementation and the risk mitigations that will be applied. Performance Qualifications are a collection of test cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification tests the requirements defined in the Business Requirements Specification. For SaaS systems, Installation Qualification and Operational Qualification are performed by the vendor, who should provide certificates or supporting documentation that they were done.
When all validation tasks are successfully completed and documented in the Validation report, the last step is to finalise SOPs and/or WIs and made them available to users within the company’s Quality Management System (QMS).
The implementation of a new system consists of many tasks, involves different functions and requires accurate evaluations to ensure the system is rolled out within an organization in compliance with company processes and regulatory requirements. It requires a significant investment of time and resources, project management is essential to meet implementation timelines, management and coordination of resources. The main challenges to face are achieving timelines by maintaining budget, allocating appropriate resources and assuring compliance to company standards and regulatory requirements.