Clinical trials Research Organization
Full Service Contract Research Organization (CRO) for Medical Device Industry
Medical device clinical trials require a host of resources that many companies don’t have in house. As a full-service contract research organization (CRO) focused on the medical device industry, Aptiv Solutions is uniquely able to support you through all phases of clinical trial development and testing. At any one time we are involved in the design, management, and monitoring of 20 to 30 medical device studies, representing varied technologies and therapeutic areas. Medical device clinical trials are one of the key focuses of our business.
Working with your team, we will help you to design and implement a clinical trial that will best meet your business needs, whether you need clinical data to support a regulatory pre-market submission, drive product adoption, support product reimbursement, or monitor post-market product use.
What is a CRO?
CRO is an acronym for “Clinical Research Organization” or “Contract Research Organization”.
A CRO assists medical device companies with clinical trial strategy and protocol design, study management, data management, clinical trial monitoring, biostatical analysis, and report preparation to ensure that clinical data is collected appropriately to effectively support any necessary FDA submissions, and other global regulatory requirements.
Why use a CRO?
As medical technology continues to advance and product development becomes more complex, outsourcing to a CRO can offer a number of strategic benefits. By avoiding the need to hire additional in-house staff or purchase costly data management software, and by leveraging a CRO’s knowledge of regulatory requirements, clients can realize significant cost-savings and often a faster, more efficient path to market.
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Data and Safety Monitoring Committees in Clinical Trials (Chapman & Hall/CRC Biostatistics Series)
Book (Chapman and Hall/CRC)