Dear Sponsor, Dear CRO, Dear Patient, Dear Investigator
In Europe and more specifically Belgium, Direct To Patient (D2P) shipments are limited within the current regulatory framework. Considering the growing enthusiasm of pharma companies, investigators and patients for D2P shipments in the USA, we want to investigate if the European market should not consider adapting its regulations in order to respond to this new demand.
A working group has been established with the participation of the Belgian Federal Agency for Medicines and Health Products (FAMHP), the Ministry of Social Affairs & Public Health, Patient organizations, the Industry, Academic Organizations and finally Industry Associations to further explore these options and understand the regulatory implications.
This working group is reaching out to you as stakeholder in Clinical Trials, so that you may share your experiences and show your future interest on D2P by completing this questionnaire.
The survey will help us define and scope the needs of D2P shipments in EU and help us support a change in the current regulations so that we can better meet the evolving needs of patients participating in clinical trials.
Thank you for taking the time to answer this questionnaire by 31st July 2017.
For the purpose of this questionnaire, D2P means shipments of IMP from a clinical site to a patient, from a pharmacy to a patient or shipments from a depot to a patient.
For the purpose of this questionnaire, Company refers to the whole organization (on a global scale). Some questions refer to previous experience with D2P that may exist within your organization at an international level.
It is possible that answering this questionnaire may require the input of several different business units of your organization. We would appreciate it if you could consolidate the information of your colleagues and provide a company-wide response to the questionnaire.
Your feedback will be treated anonymously.
If you wish to receive the survey’s output, you can of course provide your email.
https://www.surveymonkey.co.uk/r/D2PSponsor (Sponsor Survey)
https://www.surveymonkey.co.uk/r/6TV6MQX (Patient Survey)
https://www.surveymonkey.co.uk/r/RYSM8WYCRO (CRO Survey)
https://www.surveymonkey.co.uk/r/VQHSKX2Investigators (Investigator Survey)
The D2P Working Group
Welcome to the website of the Belgian association of Clinical Research Organizations, BeCRO.
BeCRO is a professional organization of Belgian Contract Research Organizations (CROs) which are supporting the pharmaceutical, biotechnology and medical devices industry in the clinical research and development of new products. The result of the combined industry efforts, including BeCRO members, is the availability of new treatments and therapies from which patients can benefit.
BeCRO is a leading voice in the Belgian R&D industry, representing its members towards the other stakeholders, being the pharmaceutical, biotechnology and medical device industry, the authorities, the investigational sites and last but not least the patients. The goal is also to create public awareness around the importance to conduct clinical trials in Belgium.
BeCRO represents currently about 30 Belgian CROs, going from small companies to affiliates from global leading contract research organizations. All of them have the same common goal; conducting safe and ethical clinical studies following the latest industry developments and guidelines leading to higher efficiency while maintaining the highest quality standards. BeCRO actively supports its members in this area by providing the latest industry updates and clinical studies specific training.
BeCRO is a member of the European Federation of Clinical Research Organizations (EUCROF) representing 300 CROs in 17 countries. BeCRO plays a leading role in this European organization via its active participation in most EUCROF working groups and through its representation in the Management Board of the Federation.
BeCRO will continue to play an active role in the national and international, rapid and continuous changing environment of clinical research.