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Choosing your EDC Solutions Provider

EDC systems are the industry standard for accurate, cost-effective, and safe collection of data. However, insufficient expertise in designing data validation plans, miscommunication between sponsors and EDC vendors about the former’s expectations and the latter’s capacities, poorly defined metrics, and delays in data entry and query resolution can all be major obstacles for the successful utilization of EDC. In order to provide a seamless service and ensure high-quality of EDC services, ClinSearch has developed this expertise in-house. Our data management department has accumulated expert knowledge in designing and setting up EDC systems for your clinical, post-marketing, and compassionate-use studies. We can assist you in preparing data validation plans, training EDC users, developing the optimal visual implementation solutions for your studies, and customizing data reports. During the whole process, the expertise of our team will be at your disposal! The process of setting up EDC starts with setting up objectives for the system by the sponsor or with the help of ClinSearch. This is followed by defining the regulatory compliance for the EDC, as well as the users, interfaces, and target processes. Then the rules and requirements are defined, the relevant processes, support functions, and data protection and data repository policies. Due to our expertise, we have the opportunity to be quick and efficient in proposing the best designs for your needs, accounting for risks for the functionality of the EDC and the quality of the data. Our EDC solutions offer the following features:

Customization of electronic case report forms(eCRFs);

Provision of a web-based platform, providing sites with access to data entry, thus managing a cleaning and locking process on-the-go, in which any queries against the data are resolved;

Adaptation of the final data to SAS dataset.

We also have an integrated statistics and medical writing department, as well as pharmacovigilance and materiovigilance experts, who can fulfill the safety design and monitoring needs for your projects. Our safety team is working on projects with encoding and review of terms, reported in clinical trials, medical history, prior or concomitant treatments; as well as identification of missing and discrepant data between SAE reports and clinical databases. We use the industry-accepted dictionaries MedDRA and WHOdrug and we have a full-time MedDRA-certified staff member, Mme Marianne Morineau, MD. Furthermore, MedDRA coding is integrated into our EDC solutions, so physicians have the opportunity to code immediately. If you are looking to start a study soon and want to explore the benefits of an EDC platform or need some ad-hoc medical writing or statistics services, do not hesitate to contact us. We will also be attending the EuroPCR in Paris, so we would be happy to schedule a meeting.

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Horizon 2020- is Your Device Eligible for Funding?

Horizon 2020, the biggest EU Research and Innovation program ever with €80 billion of funding available over 7 years, has now existed for over a year. By funding multidisciplinary and multi-partner projects, Horizon 2020 aims at securing Europe’s global competitiveness by promoting world-class science, removing barriers to innovation, and enabling the public and private sectors to work together.

The program focuses on 3 main topics of priority: excellent science, competitive industry, and tackling societal challenges. “Health, demographic change and well-being” is an important focus of the program, with 1.2 billion in funding available to innovators in 2014 and 2015 alone.

Projects related to development of innovative medical devices, active implantable medical devices, in vitro diagnostic devices, or innovative procedures involving any of them, are fully eligible to submit a proposal in the framework of the Horizon 2020 program. The rules and procedures for requesting a grant have been made simple, in order for participants to focus on what is most important: research, innovation, and results.

How to Request a Grant?

If you have proof that your device or procedure provides tangible healthcare benefits, you need to keep an eye on the calls for proposals available on the online participant portal. A new work program is published every two years, including the calls for proposals occurring during this time frame.

Most calls accept applications by any consortium of at least three legal entities. The only condition: each entity must be established in an EU member state or associated country.

Getting funding is, however, just one of a series of steps you need to take to access the European market. Managing new products or procedures to achieve commercialization require them to go through a conformity assessment procedure, allowing them to obtain CE marking. This involves among other things the presentation of clinical data, which may or must—depending on the device, be obtained via clinical trials. Choosing a good local partner for this is vital, but difficult, as you need to navigate the factors of quality, cost, and the ability to split risks and shorten your time to market.

 Why Partner with ClinSearch?

·     We have been active in Europe and the MENA region since 1999, acquiring extensive experience with the challenges of clinical studies and regulatory approvals.

·     Our multilingual experts include scientific and medical advisors, medical writers, monitors, project managers, statisticians, and data specialists, working together to deliver the best solution for your needs.

·      We dispose of an in-house data management function, able to develop an EDC suited to your needs in a timely fashion.

·   Our integrated medical writing and statistics department guides you through the complexities of clinical data.

·      Our centralized project management function ensures quality across Europa and MENA.

·      We can support you beyond CE marking, in the design and conduct of post-marketing studies, as well as obtaining favorable reimbursement rates.

·    In addition, our site management service in Eastern Europe, MDKeys, was developed in response to client requests for shortened recruitment times for patients and cost-effective solutions. The participating sites in the network have been screened and audited to verify conformity with international regulations and the conditions of working together have been negotiated: meaning they are ready to start recruiting patients for your study on a short notice.

To learn more about ClinSearch or MDKEys, please visit http://www.clinsearch.net/ or http://www.mdkeys.com/.

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