Park IP Highlights Clinical Outsourcing & Partnering World Europe 2016
Park IP recently attended Clinical Outsourcing and Partnering World Europe 2016 in London. Marta Motta, Park IP’s Director of Client Solutions for Life Sciences, took part in the event and in this blog, shares some of the main discussions and key highlights.
The overall objective of the Clinical Outsourcing and Partnering World event focused on how the industry can improve clinical trials and transform clinical practice by better collaboration, innovation and quality. There were many interesting presentations and sessions. Here are four key highlights from the event:
HIGHLIGHT ONE: Partnership between Pharmaceutical Companies and CROs
One of the main discussions that took place at this year’s Clinical Outsourcing and Partnering World Europe 2016 event, was the trend for more integration between the pharmaceutical companies and the CROs (Contract Research Organization). It highlighted the trend that the two bodies are starting to work closer together in a partnership rather than a more traditional vendor-supplier relationship. More and more pharmaceutical companies are choosing a handful of CROs and committing to work with them as partners, not just vendors, to increase efficiency and maintain long-term relationships throughout clinical trials.
Continuing on the theme of working relationships within the industry, one of the ongoing issues is that there is a very high turnover of Clinical Trial Assistants (CTA). In order to have a successful trial, you need good teamwork with the CRO as well as a solid CRA team with in-depth expertise. Many pharmaceutical companies are starting to address the issue of CRA retention with additional training and incentive.
HIGHLIGHT TWO: New EU Clinical Trial Regulations
The new EU clinical trial regulations is one of the most significant changes in legislation in the past decade. Applicants will submit a single electronic application instead of one for each country. This new regulation was approved in April 2014 and entered into force on June 16, 2014; however, will apply no earlier than May 28, 2016. The overriding benefit of this new legislation is that there is an authorization procedure for clinical trials based on a single submission dossier via a single EU portal, leading to a single decision on all aspects per member state. It replaces the previous EU Clinical Trial Directive (EUTD), which had been criticized because it was interpreted and implemented differently in different member states, resulting in increased costs, delays and administration.
HIGHLIGHT THREE: Digital Revolution
We are seeing a trend for increased electronic documentation. The life sciences and pharmaceutical industry is quite a conservative one and it has taken longer than other industries to embrace use of technology for patient and trial documentation. Companies are starting to utilize ePROs, Electronic Informed Consent or eSource for sites and patients. Documentation is such an important part of a clinical trial. Migrating to a more digital system will create a more efficient and reliable system.
HIGHLIGHT FOUR: Importance of Accurate Documentation in Multiple Languages
One area of the industry that remains relatively immature is the importance of translation and accurate documentation in multiple languages. Documentation is a critical part of the extremely regulated trial process. Translation is a key component if content is to be understood by people in other countries. Any clinical trial content and document must be represented and understood in all relevant languages. Whether translating investigation brochures to promote a clinical trial at a hospital or communication to the FDA, content must be accurate and translated professionally by experts.
Park IP Translations is committed to supporting changing trends in all regulated industries, including life sciences and the pharmaceutical industry. We provide localization and translation services that meet client’s needs for documentation, digital content and specialized content types.
Did you attend Clinical Outsourcing & Partnering World Europe 2016? If you have any feedback on my highlights or would like to share your thoughts, please send me an email: firstname.lastname@example.org.
Based in London, Marta Motta is Director of Client Solutions for Life Sciences at Park IP Translations.