Industry Provider Profiles
Research Dynamics Consulting Group, Ltd.
Company Type Services
Research Dynamics is a full service Clinical Research Organization (CRO) that provides high quality, flexible clinical research services, training, and consulting to the pharmaceutical, biotech, device industries as well as to investigators and academic medical centers. We use innovative technologies, experienced research professionals, and a commitment to clients through product development to approval to ensure that patients benefit from novel therapies as soon as possible.
The company was founded in 1993 by the President/CEO Lorraine D. Ellis, MS, MBA. During 20years of providing service, we have won several accolades including Top 100 Growing Rochester Companies (2002, 2003, 2004) and Ernst and Young Entrepreneur of the Year (2004).
What is unique about Research Dynamics?
- Technology- Integrated with reenergized processes to complete your trial faster and at lower cost. We have optimized the use of EDC for more effective monitoring with fewer monitoring visits.
- Experience– Project staff are selected for their experience on similar projects.
- Expertise – And experience to resolve emerging issues before they become problems.
- Relationships – That care about your product and your trial.
- Training – Foundation that improves Investigator Site performance.
- Transparency – Project information and data available 24/7 through web-based CTMS and EDC systems.
Research Dynamics Consulting Group staff are trained to use our efficient processes and state of the art technology, to respond quickly to issues, and address problems as they occur in real time. Our innovative processes maximize technology tools to provide higher quality data more efficiently and at lower cost.
CRO services: As a full service CRO we concentrate on providing our core competencies of clinical services from site identification to final clean data collection. These activities include site monitoring, site management, project management, regulatory document management and remote monitoring with EDC. This focus offers our sponsors the most experience and the best expertise in these activities. We do what we do and we do it well.
If you require full CRO services, we have partnered with “best-in-class” experts in the other disciplines required for clinical research such as regulatory, data management, statistics, laboratories, and more, to provide you the best in these services. Please read about our partners to learn about these services.
If you require global services, we have partnered with several European CROs to provide clinical research services in Eastern and Western Europe. Please read about our global capabilities to learn more.
- Project Management
- eCRF design and EDC
- Site Selection
- Study Start Up
- Investigation and Project Staff Training
- Clinical Site Monitoring
- Site Management
- Data Management
- Bio Statistics
- Medical Writing
- Medical Monitoring
- QA Auditing
We have extensive experience and focus on the following therapeutic areas:
- Critical care
- Endocrinology (especially diabetic studies)
- HIV and Hepatitis
- Infectious diseases
- Wound Healing
- Device trials
- Gene therapy trials
- CNS & Neurology
- Molecular Diagnostics
- In-Vitro Studies
We have experience in several therapeutic areas and with a variety of medical products. Because of our unique model, we are continually gaining experience in new areas and with new products.
Our clinical trial experience spans a wide range of products from the pharmaceutical, medical device and biotech industries.
- Oral dosage forms
- Topical drugs
- Class 2 and 3 medical devices
- Gene therapy products
- Diagnostics and In-Vitro
Medical Devices and In-Vitro Studies:
We are familiar with the differing requirements of device studies compared to drug studies. Device trials are a significant part of our work so we have the experience you need for your device trials. Currently, we are working on sever in-vitro studies with new trial requirements as the FDA requirements are changing to include more patient data. Since each device trial is unique, contact us to discuss your device study in more detail.
With the company’s foundation in training we continue to provide GCP and other topics in clinical research in a variety of formats. Our on-site GCP classes can be standard or customized for topics and length of class. In 15 years we have taught thousands of students and hundreds of companies how to conduct clinical research and GCP requirements. Our clients include small to large pharmaceutical companies, medical device companies, biotech companies, academic medical centers, investigator sites, and other organizations. Learn more.
We have been noted as one of the top training companies in the industry. The strength of our knowledge is demonstrated by our participation in the development of several industry certification programs and tests.
We have first class products designed to maximize training:
GCP for the Clinical Investigators
A self-study course presented in a workbook format. It is designed to train the Clinical Investigator on the fundamental FDA regulations and Good Clinical Practice Guidelines.
CRA and CRC Activity Guides
Handy books that guide CRAs and CRCs through their daily clinical research activities while improving GCP compliance. Including chronological step-by-step checklists that are easy to follow from first receipt of a protocol to study closeout.
Standard Operating Procedure Templates for the Clinical Site
Our 26 SOP templates provide a "quick start" on developing your own custom SOPs. The basic methods are clearly written and ready for your specific procedures to be added. Designed to improve regulatory compliance, enhance staff performance, reduce supervisory and management time, and standardize training and research practices. Available on CD.
Webinar based trainings
These short courses delivered directly to your computer provide the latest regulatory guidance and how to apply it to your clinical research activities. These webinars can be used to update knowledge for experienced staff or as a series of educational opportunities for the newer staff. New topics are added monthly covering the latest FDA information to help keep staff ahead of the curve.
Our consulting services span several areas of expertise. We assist new companies with their clinical development plans and provide advice on clinical trials. We work with a variety of organizations to improve GCP compliance, productivity, quality, and cost-effectiveness in their clinical research operations. We conduct GCP audits and provide advice on how to improve study conduct and GCP compliance at that organization.
Research Dynamics is committed to providing its clients with the best possible training, CRO services and support. We adhere to the highest standards of excellence.
Research Dynamics Consulting Group, Ltd.
1250 Pittsford Victor Rd.
Bldg. 100, Ste. 110
Pittsford, NY 14534
585-381-1350 ext. 228
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