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Concentrics Research LLC

Description: 

"Client-Centered Strategies"

Concentrics Research is a unique CRO specializing in Rx-to-OTC Switch and late-stage (Phase II-IV) research. With offices in New Jersey and Indiana, we are positioned to deliver superior customer service to the pharmaceutical, device and consumer health industries. Often referred as the "Thinking CRO", we provide custom and creative solutions to meet the needs of each individual client with their specific goals in mind.

 

Concentrics' service, stability and expertise provide our clients with extra value in every study. Our low staff turnover rate of <5% and our return business rate of more than 90% demonstrates our commitment to our staff and our clients. At Concentrics, we are "centered" around you - your specific drug or device, your specific research needs, your commercialization goals. For over 25 years, our staff of specialists has provided support to sponsors and industry for study design and execution focusing on performance and service excellence.

 

We design your program with your goals and objectives in mind and then the build from those goals, often developing unique and innovative solutions. Studies can often be synergized and sequenced to optimize timelines and budgets.


Products and Services

  • Program and Regulatory Strategy
  • FDA Preparation and Support
  • Protocol Development
  • Project Management
  • CRF, ICF, Diary Development
  • Central IRB
  • Site Selection, Contracting and Management
  • Specialized Patient Recruitment
  • Adverse Event Monitoring
  • Monitoring
  • IVR, EDC Solutions
  • Central Medical Operations Group
  • Data Management
  • Biostatistics
  • Medical and Report Writing

Clinical Operations Division

At Concentrics, our staff has conducted over 800 projects in a wide range of therapeutic areas. We perform Phase II-IV clinical trials and actual use trials for Rx-to-OTC Switch programs in both prescription and consumer populations. Nearly 65% of our work is in the customized Phase IV area related to health outcomes, quality of life, new indications, claims, head-to-head comparisons, post-marketing surveillance, safety monitoring and long-term tracking studies.

 

Regulated Healthcare Market Research Division

Our Regulated Healthcare Market Research Division is talented in designing and conducting custom qualitative and quantitative research. Our research includes comprehension testing on labeling, patient brochures, instructions for use, patient leaflets and education. In addition, this group is responsible for designing and conducting studies for REMS (risk evaluation mitigation strategy) requirements, concept evaluations, attitude and usage, claims support, and product testing with consumers, patients, healthcare professionals and caregivers.

 

Rx-to-OTC Switch

With over a quarter-century worth of expertise, no service provider has more experience in regulatory strategy development, program design and execution. Concentrics has worked on more than 75% of the successful Switch programs and have excellent, working relationships with CDER, CDRH, CBER, NIH, CDC and CHPA. In addition to our regulated healthcare market research services we perform self-selection studies, special population studies, actual use and post-launch studies for Switch programs. We are experienced recruiting special populations such as consumers of lower literacy and those with special medical conditions.

 

Pre-Approval and Post-Approval Integrated Research

Our company is unique, in that we have two distinctly different and separate divisions within the same facility. The two divisions, Clinical Operations and Regulated Healthcare Market Research, operate independently when needed and often work together on studies that include both clinical and market research endpoints. This hybrid capability allows us to capitalize on early market insights, minimize timelines, and enhance commercialization efforts.

 

Services: 

Claims Support Studies/Safety and Efficacy Studies, Consulting, Consumer Testing, Patient Compliance, Patient Information Leaflets (PIL)/ Labeling, Project Management, Protocol Development, Regulatory Affairs/Regulatory Strategy, Rx to OTC Switch, Trial Management

Contact Information: 

Concentrics Research LLC
9335 Delegates Row
Indianapolis, IN, 46240, USA
Phone : 3177063200
Fax : 3177052175
Internet : www.concentricsresearch.com
Email : julie.aker@concentricsresearch.com
Contact Person : Julie Aker, President and CEO