Impact of CTIS on Medical Writing - Perspective of a Contract Research Organisation (CRO)

9:40 AM - 10:25 AM

An effective CRO must be one step ahead of its customers, including keeping up to date with regulations and available training, to be able to properly advise and consult. But how can we do this when it has taken years for the EU CTR to become effective and then trainings are drip fed with everyone, from academia, the smallest biotech companies to the largest multinational pharmaceutical companies and CROs, all in the same boat and learning as we go?

Time must be invested in establishing new processes, writing new SOPs, providing estimated hours for completion of these new tasks and associated budgets.

Customers want confirmation we are not passing any of these ‘learning’ costs on to them.

New relationships are being established as we get to know other areas of the business and work even more closely with our regulatory and anonymisation teams.

Lessons must be learnt and shared so we all gain awareness and customers are ensured that we, as a provider, will perform the required activities on time and according to the regulatory requirements.