Medical Device Clinical Affairs – Strategic & Operational Support
Proceed Clinical Ltd provide clinical evidence strategy and operational expertise to medical device manufacturers, led with a mindset of collaboration and efficiency.
Our Services
Our goal is to provide the Clinical Affairs expertise you need, when you need it, across the lifecycle of your device.
Strategy; Support and guide your understanding of expected clinical evidence needed for your device, from securing regulatory approval to Post Market Clinical Follow Up
Resourcing; Provide ad hoc guidance and advice, project specific or fractional Clinical Affairs support for planned or current clinical programs
Execution; Management and oversight of clinical evidence projects
Here are some frequent queries we can support;
What clinical evidence and activities will I need to consider before, during and after I get approval for my device?
Do I really need to run a clinical investigation?
I am seeking investment/building my costing forecast – what will my clinical program cost in time and money to deliver?
Do I have the right strategy for success?
Can you help us run our study?
Why choose Proceed Clinical?
I’m Nancy Boodhun, founder of Proceed Clinical Ltd.
For more than 20 years, I have been fortunate to work within the medical device space. During that time I’ve served patients directly, worked closely with clinicians across the world in the development of new devices, designed and executed global clinical evidence strategies for new and existing products, and guided manufacturers with service solutions to conduct their studies successfully.
In all those environments, I’ve never been far from directly feeling the impact of the evolution of regulations, standards and authority expectations for providing “sufficient” clinical evidence to demonstrate device safety, performance and reimbursement. Add in the requirements of study execution across different markets, and comprehension of the methods and tools to collect data and run compliant clinical investigations, I appreciate that Clinical Affairs can be a daunting and complex prospect!
I understand the challenges to manufacturers, whatever their size, to generate the right evidence, and how that can affect business decision making. Designing and executing a clinical strategy to support a product pre or post market is a significant commitment – it’s important to get it right.
Proceed Clinical will provide a collaborative, independent source of support and advice for device manufacturers to enable definition, planning and execution of their clinical evidence strategy to reach business objectives (and study endpoints!).
Please don’t hesitate to contact us for an informal discussion on how Proceed Clinical can support you, whatever stage you are at in the journey.
Contact us for more information
Please use the form or see the contact details below:
Telephone:
+44 (0)7419 904 260
Email:
[email protected]
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