Clinical & Contract Research Association (CCRA) April Updates

The latest updates from the Clinical & Contract Research Association (CCRA) for the month of April.

New Members 

CCRA is delighted to welcome two new members this month, from opposite ends of the company size spectrum:

• Medidata Solutions International Ltd is the EMEA headquarters of Medidata, a company that is leading the digital transformation of life sciences with the world’s largest platform for clinical development, commercial, and real-world data.
• PM Clinical Quality Consulting Ltd provides services including cQMS support, GCP advice and training and inspections support to the Biopharmaceutical industry.

New Working Group 

As can be imagined, the COVID 19 pandemic has caused a much increased workload for the Clinical and Contract Research Association (CCRA) and many of its member companies.  This has precipitated the establishment or formalisation of existing specialist groups. 

One such is the Regulatory Affairs Working Group, established in early 2021, with an initial mandate to:

• Keep a watching brief on the status of the current Trade Negotiations post-Brexit
• Provide a forum to discuss the potential challenges which may lie ahead for our CRO members during the Brexit transition period
• Facilitate the discussion of such challenges with the relevant assessment bodies. Our challenges are those of the CCRA members we represent and their stakeholders.  We are due to engage with DHSC on a quarterly basis.

The Working Group meets regularly and the minutes of past meetings, dates and agendas of future meetings are available for members on the CCRA website, or by emailing mail@ccra.org.uk.

Clinical Trials Specialist Apprenticeships

CCRA is acutely aware of the skills shortage facing clinical research in the UK. In a small way it is assisting in putting forward highly qualified candidates for selection as assessors of candidates who have completed the Clinical Trial Apprenticeship Degree taught by the University of Kent in association with CPL Ltd.

More details of the degree and the apprenticeship scheme will be available, imminently, on the CCRA website www.ccra.org.uk.

Early Notice For May 

International Clinical Trials Day 

The 20th May is International Clinical Trials Day. The day celebrates the anniversary of the first clinical trial, by James Lind in 1747, into the causes of scurvy on board the HMS Salisbury.

To coincide with this, the CCRA, together with organisations such as MHRA, ABPI, IFPMA etc, will be submitting articles to go into the Clinical Trials publication to be produced by MediaPlanet and which will be included in every copy of New Scientist for that week. A link will be available on the CCRA website.