The road from non-clinical to the clinical phase is challenging. There is even a descriptive term for this transition: The valley of death.
A full-service CRO is the key to success
Knowledge is the best weapon in overcoming challenges in all development phases of pharmaceutical, medical device or biotech innovations.
When some of LINK Medicals experts recently teamed up in a webinar, covering the mentioned subject, the message was clear; having a full-service CRO as a solid partner is the key to success.
Some of the services that are central to this offering are highlighted below.
Regulatory compliance in early biotech
LINK Medical specialises in organising transit through the entire CMC-project, from initial idea to clinical phase. Setting out clear guidelines as early as the first pre-clinical ideas will help companies transition faster.
Small biotech companies are often under time pressure, but it is risky to not make enough time for CMC and validation.
Valuable support in a GMP audit
The importance of a proper GMP audit can never be over-emphasised. Regulations are tightening, even for areas not regulated before.
Experts from LINK Medical support biotech companies in taking good decisions and provide quality assurance support throughout the GMP audit – from initial set-up to production and continuous quality control.
Make time for scientific advice
“Obtaining good scientific advice is a way to stay ahead of regulations, and establish trust”, explains Marie Moores, Executive Vice President Early Development. Especially in the very early stages.
Involve biostatisticians early on
Companies need to involve a trial-statistician as early as possible to build solid design on the projects, scaled up to the correct power.
A LINK Medical biostatistician can help organise sample size calculations to make sure that enough patients are included. A biostatistician at LINK Medical will help to define the primary objectives and end-points of any study and to make the correct decision on which samples and measures to include.
Data managers also need to be involved as early as possible, to ensure that data is properly collected and matches the chosen clinical endpoints.
It is hard for small biotech companies to know which standards to use, and to make the most of data collecting and management. As a full-service CRO, LINK Medical offers end-to-end services for all activities from idea to setting up qualitative data records.
Clinical trial safety and new regulations
With the new MDR of 2021 and the upcoming IVDR in 2022, the safety aspect has never been clearer. Reducing the number of efficacy- and safety-related failures comes down to good planning and strategy development fulfilling all stakeholder needs during the whole development process. LINK Medical experts work with this every day.
“There could be pitfalls that, identified early, can be overcome with relatively small means. This should be done through a strategy that is set long before clinical trials even begin”, said Tina Elbering, Director of International Safety Operations at LINK Medical.
A common theme - plan thoroughly before you start.
A great deal of risk mitigation and time-saving comes from early planning. Whoever you choose to help you through the valley of death, initiate the discussions very early on. Experts at LINK Medical are ready and eager to help you.