As the implementation of ICH GCP E6 Rev 2 (referred to as ‘Rev 2’) draws closer (current best guess is November this year) the need to understand, plan for and become compliant with the new guideline grows stronger. In order to help industry as a whole, and individual companies specifically to tackle this challenge, TRI and Wider Perspectives have formed a unique partnership.
Why the partnership?
For many companies becoming compliant with the revised guideline is not going to be a straightforward process. It is a multi-functional and multi-disciplinary challenge and will require a solution comprised of evaluation, process change, mind set change, training and technology.
For more than 15 years, the team at Wider Perspectives have been supporting companies with their compliance to ICH GCP through the conduct of audits as well as supporting companies in their preparation for, and remediation following regulatory inspection against the guideline and applicable regulations. Their experience in what it means to be ‘compliant’ and helping companies achieve that is second to none.
For a very similar length of time the management team of TRI has been helping companies improve their clinical trial capabilities through process improvement, training, change management and technology development and implementation. In 2013, TRI initiated the development of a cloud based technology for risk management, risk-based monitoring and quality oversight. The solution, known as OPRA is currently in production across multiple studies and has an ever growing client base.
The pairing of these two sets of experiences, skill sets and the assets owned by both companies creates a solution which covers every aspect of becoming compliant, and the best part….it’s available today!
What have we done so far?
Neither company has been ones for resting on its laurels and waiting for change to happen. Since the autumn of 2015 we have been working together to scrutinise the proposed changes and defining the optimal approach to understanding and implementing the changes.
We completed an assessment of the changes and developed a matrix defining the process, change management and technology aspects required for each section of the changes. In order to start raising awareness levels around the industry we ran two free webinars in February and March this year, which summarised the findings of that analysis. Both events were oversubscribed and so the recording has been made available to those who did not make the capacity level. That recording is available on request by contacting firstname.lastname@example.org
In order to make the awareness of Rev 2 more formal and to guide companies on the path to implementation we have set up a series of online training and certification events. These 90 minute, instructor led online courses will help companies and individuals understand the changes in much more depth, understand how it will impact them, and how to go about implementing the changes required in order to become compliant. These events will be ongoing through the rest of the year, starting in May. The registration link is as follows:
What are we doing going forward?
As well as maintaining our separate businesses, this partnership is now working directly with companies to help them assess the most efficient route to becoming compliant as well as the adoption of the prescribed processes, such as risk assessment, risk management and risk-based monitoring. The partnership between TRI and Wider Perspectives allows a complete end-to-end solution. The services we are currently providing are listed below:
- Assessment of current state
- Definition of goals and vision for Rev 2 compliance and risk-based monitoring
- Assessment and updates to processes, SOPs, and role definitions in order to ensure documentation compliance
- Training in new procedures, risk assessment and risk-based monitoring
- Selection and implementation of risk assessment and risk-based monitoring technology
- Change management
Not every company needs all of the above, and the journey to compliance is very much dependent on current capabilities and future aspirations. It is for this reason that whilst the guideline (and regulations) are a constant, we treat each customer very much as an individual and it is only through our experience and the expertise of our consultants that we are able to help guide companies to the optimal route to compliance and success.
How do you find out more?
Whatever your needs and plans with regards to Rev 2 compliance, risk assessment, risk management or risk-based monitoring we’d love to hear from you.
There are a number of ways to make contact and find out more about who we are and what we do:
Join over 1000 members on our linked in group, ‘Risk-based monitoring in Clinical Trials’