How to outsource your study data:
Functional Service Provision: relying on a specialized clinical data company to provide a scalable team of resources at hourly or daily rates for a determined period of time.
Implementing a cloud-based solution improves the quality of data through automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.
Since statisticians involved in medical device trials must balance potentially expensive products, long follow up periods, possibly large sample sizes and unique endpoints, sophisticated trial design can help account for these changes. The FDA accepts the use of Bayesian design in medical device trials since it combines data from previous studies and the ongoing study to make changes to the study if necessary.
CROS NT has extensive experience, both in the U.S. and Europe, in the area of medical device study design and analysis for regulatory submissions. We have worked with multiple startups and late stage device companies including work on novel, Class III devices and consulting on de novo Class II devices. If you need trial design and statistical assistance on an upcoming study, inquire about an initial consultation with one of CROS NT's principal biostatistician.
CROS NT is exhibiting at MedTec Europe 2015 in Stuttgart, Germany this April at Booth #3H55. Be sure to visit us at Europe's premier medical device conference to learn about our expertise in biostatistics and clinical data management and how we can assist your company.