WHAT IS CURED?
The need to effectively manage the relationship between a Sponsor Organisation and a Clinical Research Organisation (CRO) is increasingly being recognised as crucial to successfully delivering clinical research projects. The CURED framework has been many years in the making and is the product of bringing together three key factors: domain experience, academic research, and looking outside of clinical research for knowledge & lessons.
CURED is a free Code
of Practice published
in partnership with
the ICR that de-risks
clinical trials and
improves performance
The CURED Framework Ltd
Is an organisation that helps
you intelligently apply
CURED & create a digital feedback loop that evidences your growth
and success
The genesis of CURED is in experience, we have immersed ourselves in the day to day problems that affect projects and programs in clinical research and other project-focused industries. Using decades of collective experience in multiple fields, it is clear that the same symptoms are affecting projects, and that some kind of systemic issues are at play.
CURED is about defining an operating model that delivers these enablers and providing a
method of identifying the associated successful outcomes.
The framework provides a number of guiding principles by which the relationship between Sponsor and CRO is effectively managed. These principles make up the CURED manifesto for the successful delivery of clinical research projects:
UNDERSTANDING
We emphasise communication to facilitate a shared understanding
We recognise the
need for both inter and
intra-organisation understanding
We ensure adequacy, constancy and availability of resources, including people
RESOURCES
We engage in collaborative education initiatives to deliver practical knowledge
EDUCATION
DELEGATION
We stress the importance of "letting go" and delegating authority and responsibility while driving accountability
We recognise the important influence of the contract on relationships
We cultivate the right behaviours through incentivisation and
discretionary
awards
CONTRACT
A BREAKDOWN OF THE ELEMENTS
CONTRACT
Through "contractual completeness" there is a promotion of shared goals and expectations between the sponsor and the CRO. This reduces the likelihood of destructive opportunistic behaviour by either the sponsor or the CRO or concealment by the CRO of issues that ultimately have negative consequences for the project; avoids excessively costly and unnecessary monitoring of the CRO's performance by the Sponsor.
UNDERSTANDING
Through effective inter- and intra-organisation communication, shared understanding about the goals and the risks are promoted, and information asymmetry is reduced.
RESOURCES
Through having the right people in place in both sponsor and CRO organisations and retaining them as required for the duration of the clinical trial, agency-related problems are addressed, and trust that has been built up between the Sponsor and CRO is not lost.
EDUCATION
Through robust training programmes in project management competencies, involving both hard and soft skills, within the sponsor organisation, alongside activities that communicate expectations of the sponsor to the CRO, agency-related problems are addressed.
DELEGATION
Through the Sponsor truly "letting go" of aspects of the clinical trial and trusting the CRO to deliver, the CRO is empowered, leading to a flexible, trusting and productive relationship between the two parties.
TESTIMONIALS
VISUALISING MATURITY
As part of CURED, we share anonymised data from the implementation and ongoing use of the framework.
One of our primary strengths is in expert research and analytical study. We use tangible evidence of your successful growth to build a sustainable culture of continuous improvement. CURED uses industry leading A.I powered analytics and a wealth of academic expertise to deliver uncompromising insight and value to your projects, this is how you see the return on your investment in change.
Being part of this is a critical part of the process as it allows you to not only evidence growth and returns but also to benchmark yourself against similar projects and organisations. Sharing knowledge has been the catalyst for exponential growth in technology, and now we are applying these principles to delivering a positive impact on clinical research.
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The authors are grateful for the help and support from the following individuals and organisations in writing this Code of Practice. Firstly, we thank the Institute of Clinical Research (ICR) for their key role in sponsoring the Code of Practice and for providing invaluable expertise to support its development. Thanks also to The Association of Project Management (APM) who provided pump-prime funding through their Research Fund for the academic research that was conducted in developing the CURED framework.
Acknowledgments
