Berlin – 30 Apr 2015 – KCR, a Contract Research Organization (CRO), operating in 19 countries in Europe as well as the U.S., conducted a short survey during this year’s DIA EuroMeeting held on 13-15 April 2015 in Paris. The aim was to gather the industry’s perspective on the Voluntary Harmonization Procedure (VHP) adoption as well as to gather an insight into the CRO selection process for clinical trials conduct. Everybody visiting KCR’s interactive stand was able to express their thoughts by taking part in the online poll.
“We decided to ask the DIA participants about the VHP to understand how the procedure is actually adopted,” said Anna Baran, Chief Medical Officer at KCR. “The clinical trial approval process is one of the most critical and time-consuming steps of the study conduct. If the study is to be conducted in two or more EU member states, the VHP simplifies the application in regards to timeliness, quality requirements of the data content and the method of submission.”
KCR’s survey has shown that a significant group of the voting participants (38 per cent) believes that VHP is a good alternative for standard national procedures of the trial registration process, however the whole procedure seems to be not clear enough (19 per cent). The poll identified the following concerns: unknown risk related to such a new and ground-breaking procedure (16 per cent) and the level of preparation of the local regulatory authorities (28 per cent).
“Currently the local regulatory requirements with regards to clinical trial application differ significantly even across the EU member countries. Only extensive knowledge and experience in submission processes allow for the preparation of submission packages solely in accordance with all Regulatory Agency/Ethical Committee (RA/EC) requirements to obtain the clinical trial approval within short time, thus regulatory submissions are very often subcontracted by sponsors to the CRO companies,” added Ms. Baran.
KCR’s poll confirmed that the regulatory process is quite often forwarded to CROs (13 per cent), however clinical trial protocol development/protocol writing services are more likely to stay within the sponsor ownership (56 per cent). Another lesson learned from the survey was that mid-sized CROs are considered the most suitable for supporting clinical trial (75 per cent), with price and experience being the second point for partner selection (13 per cent).
“Clinical trial regulations, the scientific approach as well as the business model of clinical trials are dynamically changing with innovations often witnessed on a monthly basis. Working in such a challenging environment requires particular abilities for adaptation and sufficient adjustment, as well as time and cost-effective solutions,” summarized Mike Jagielski, President & CEO of KCR. “Therefore, apart from know-how and experience, flexibility and responsiveness are the most required attributes in successful clinical trial research.”
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KCR is a Contract Research Organization (CRO) operating across 19 countries in Europe as well as the U.S. The company is a strategic solutions provider for pharmaceutical and biotechnology firms who are looking for a reliable alternative to top tier CROs. Over 300 professionals offer full service capabilities in three main product lines: Trial Execution, Functional Service Provision (FSP) and Late Phase, across a wide range of therapeutic areas. Focusing on knowledge, quality and innovation, KCR and its services supports 12 of the Top 20 Global Pharma companies, as well as biotech firms from Europe, Israel and the U.S. on long standing contracts. For more information please visit: www.kcrcro.com.
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