Quality CRO Services: Reduce Costs and Simplify Operations.
To perform a clinical study is not an easy and quick task. It requires a highly qualified team that are familiar with the procedure needed to accomplish an investigating trial. As the world got to know that different steps of the same operation would be optimized if decentralized, the medical devices industry also have their own solution.
In this article you will get to know more about Contract Research Organization, or CRO services, an outsourced clinical support that is already available to the pharmaceutical, biotechnology and medical device industries. Keep reading!
The role of CRO services
Contract Research Organization solutions were created so the MEDTECH market could simplify and reduce costs of clinical trial proceedings. That way, the work is not concentrated in only one company, and can be done by a team that has the knowledge and the experience to perform a well-structured, safe and efficient study.
The range in which CRO services lays, stay between a large, international full-service organizations to a small, niche specialty groups, so choosing the right company to perform your research support means to find the one with the most experience in your targeted field.
It is important to know that you may transfer any or all the duties and functions related to the clinical investigation to an external organization, but the ultimate responsibility for the quality and integrity of the clinical investigation conduct shall reside with the developer of the product (sponsor).
A high standard CRO team is ready operate at every step of a clinical trial and pre-market strategies:
Creating a development plan and protocols review that are most suited for your product, as well as the legal documents adaptation and obtaining of the ethical committees and regulatory authorities’ approval. The optimal staff should be able to give personalised insights and advice that best support your needs.
Execution and Monitoring
The team continues their work, as the clinical trial begins, by controlling compliance according to the protocols developed at the planning phase. This ensures that the process will offer objective auditable evidence that meets the regulatory MDR standards. A well performed execution e monitoring provides confidence and quality to the certification.
Data’s management is the last step to guarantee success to your clinical trial or study, which means that the reports on the subject must be impeccable and in agreement with your product development needs. Make sure that the CRO company is well known for its data control and storage.
Advantages that fit your expectations
Reduced cost of the trial process
No need to hire an entire staff
Work project-by-project with an experienced team
Hiring a CRO expert provider guarantee maximum effort and accuracy of analysis, for a better price that making the same trial would cost the sponsor itself. As most of these companies work with different types of institutions (universities, foundations, research institutions and governmental organizations), they benefit from flexible resources and significant cost decrease, advantages that are passed on to the clients.
When choosing a CRO partner, a small company is most cost efficient, as they are often able to maintain lower overhead expenses, compared to their larger counterparts. The reason is that their staff is smaller, they have less office space, and lower administrative costs, which leads to a cost savings that reflects onto the total amount.
Besides the budget saving, working clinical studies separately from your already stablished staff means you will have trained, highly competent and experienced professionals assigned directly to the certification demands of your project, without the need for creating a new team inside your company, or even rearrange your existing personnel.
Eclevar’s CRO Services
ECLEVAR MEDTECH is a global CRO with more than 20 years’ experience in supporting medical device and IVD manufacturer in the MDR and IVDR transition, for all aspects of quality, regulatory and market-related issues.
By focusing on Process, Product and People, our expert team can support manufacturers in producing medical devices that meet mandatory ISO standards and help you understand the impact on your business.
Our CRO services delivers quality solutions for your research needs. We offer a range of services that are customized to meet your specific requirements, whether you are looking for full service CRO, staffing clinical or regulatory experts.