RCRI - Medical Device CRO    
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ISO 9001:2008 CERTIFIED.


RCRI Services:

 
Regulatory Affairs Regulatory Affairs
Clinical Trial Design & Management Clinical Trial Design & Management
Database Development & Compliance Database Development & Compliance
Reimbursement Strategy and Implementation Reimbursement Strategy and Implementation
Health Economics Health Economics
Quality Systems & Compliance Quality Systems & Compliance
Biostatistics Biostatistics
Venture Capital Due Diligence Venture Capital Due Diligence

 

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RCRI provides clinical database design, contract data
management, and Biostatistics to MN and the world!

Are you looking for one contract research organization to provide clinical database design, contract data management, and expert Biostatistics services in MN? Maybe you are not in Minnesota, and you are having a hard time finding all of those services under one roof? Look no further. RCRI, Inc. provides all of these services to clients all over the world.

Biostatistics MN – World Class Biostatisticians Help with
Approval Processes

RCRI’s world class biostatisticians are well known throughout the world for their contributions to the FDA and to the medical device industry. The RCRI biostatistics MN group, but can provide services to clients in MN, across the US and outside of the US as well. Popular activities include but are not limited to:
  • Sample Size Determination
  • Data Analysis Plan Development - frequentist or bayesian design
  • FDA negotiation regarding size, approach, and analytical techniques
  • Data Analysis
  • DSMB boards
  • Summary reports
  • Hypothesis testing, survival analysis, parametric testis, regression techniques, simulation modeling.
Clinical Database Design and Development – Consultants
who Understand the Industry

RCRI clinical database design and development consultants have years of medical device industry experience and understand the importance of working with the data management group and the biostatistics group to design databases that are 21 CFR part 11 compliant with screens that mimic CRFs and are complimentary to efficient and clean data entry.

Contract Data Management – Clinical Data is Key to
Clinical Trial Success!

An excellent contract data management organization is not as easy to find as you think. Your clinical trial is put at risk when you contract data management to an organization that does not have clinical experience. It is imperative that you find a contract data management organization that truly understands the importance of clean data entered in a timely fashion. RCRI's contract data management staff are salaried employees of RCRI. RCRI contract data management staff members all have clinical experience and perform data review as they enter data which lends to a higher degree of data accuracy. Because RCRI’s data management employees have clinical experience, they discover anomalous data that programmed edit checks don’t catch. Our excellent data management services and accuracy are demonstrated in our data validations which demonstrate a data entry error rate of less than .05%.

Working Together for your Clinical Trial Success!

Contract data management, clinical database design, and biostatistics services are all necessary pieces of your clinical trial. Finding those contract service providers who work together as a team under a superior quality system is an invaluable benefit to your clinical trial. Please call us to speak with members of these groups to learn more about our services.



 

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