Navigation Links
Clinsys(R) TPS Teams Provide Comprehensive Clinical Development Plans
Date:4/9/2008

Clinsys continues expansion of team and drug development and clinical trial design capabilities through Therapeutically-aligned Program Strategists.

BEDMINSTER, N.J., April 9, 2008 /PRNewswire/ -- Clinsys Clinical Research, Inc.(R), a therapeutically focused global contract research organization (CRO), today introduced its Therapeutically-aligned Program Strategists (TPS), an innovative concept for the evaluation and execution of clinical trials. The TPS teams are comprised of highly skilled and experienced professionals with defined therapeutic expertise who evaluate, create and execute all sponsor projects, from clinical development plans and clinical trial design through protocol finalization, leading to successful trial conduct.

Each TPS team consists of MDs, PhDs and a clinical operations program director with expertise in a specific therapeutic area. These strategists apply a research-oriented approach to clinical trial strategy, design and execution to either deliver a comprehensive clinical development plan or protocol, or review and critique client synopses and protocols. The TPS team also provides analysis of the competitive environment, the current standards of care and market potential. TPS services extend to design and implementation of generic and bioavailability/bioequivalence (BA/BE) trials.

"Our TPS team concept enables clients to leverage our therapeutic expertise in the way that is most beneficial to their drug development and clinical trial programs," said David E. Williams, Chief Executive Officer of Clinsys. "Regardless of whether our TPS teams are engaged from start to finish or if they are brought in to evaluate existing project components, what they deliver is the best possible trial design, clinical development plan and market positioning."

To facilitate the development, growth and success of the TPS teams, Clinsys has called on Linda Patricia Miller, MD, and promoted her to Vice President, Clinical Development, and Chief Scientific Officer. With more than 25 years of Phase I-IV clinical trial experience and 10 years of pharmaceutical experience, she will select appropriate team members and provide strategic medical and scientific guidance throughout all phases of project/program planning and execution to ensure cohesive, consistent delivery of TPS services. Dr. Miller trained at Memorial Sloan-Kettering Cancer Center in the design and conduct of new agent trials.

The TPS teams are supported by Chris Gregory, PhD, Senior Director, Clinical Development, and Nermina Nakas, MD, MPH, Director, Clinical Development. Dr. Gregory brings more than 15 years of biotechnology/pharmaceutical and academic experience, with special attention to Alzheimer disease, Parkinson disease and multiple sclerosis. Dr. Nakas applies more than 22 years of clinical, academic and industry research experience in multiple therapeutic areas, with specific emphasis on respiratory disease, dermatology and pediatrics. Joining Drs. Gregory and Nakas in Clinical Development is Daniel Wood, PhD, Senior Clinical Research Scientist. Dr. Wood develops and prepares clinical trial synopses and protocols for designated therapeutic areas.

Recently, John Oh, MD, MBA, joined Clinsys as Director, Clinical Development. He will develop the TPS pain, stroke, traumatic brain injury and spinal cord injury programs, drawing on his experience directing programs in neurorehabilitative medicine and physical medicine and rehabilitation. Prior to joining Clinsys, Dr. Oh served as Director, Medical Affairs, for a global CRO. He also assisted with development of a commercialization plan for SBIR and NIH grants for a functional MRI analysis and data management system at several start-up companies. Dr. Oh, who received his MD from Temple University and his MBA from Duke University, served as the Residency Program Director and an investigator for clinical trials at the University of North Carolina School of Medicine.

About Clinsys Clinical Research, Inc.

Clinsys Clinical Research, Inc.(R), is a therapeutically focused clinical research organization and a Jubilant Organosys company headquartered in Bedminster, New Jersey. Clinsys has operations in Raleigh, North Carolina; Philadelphia, Pennsylvania; Dusseldorf, Germany; Noida and Bangalore, India. Clinsys provides pharmaceutical, biotechnology and medical device companies a broad range of clinical research services in support of Phase I-IV drug development: project management, medical and clinical monitoring, investigator and patient recruitment, site management, biostatistics, data management, drug safety, quality assurance, regulatory services and medical writing services. Clinsys has expertise in a wide range of highly specialized therapeutic areas, including oncology, cardiovascular, central nervous system, dermatology, respiratory and allergy/immunology. Clinsys Clinical Research, Ltd., with operations in Noida and Bangalore, India, provides extensive clinical research services for Phase I-IV drug development, and operates a clinical pharmacology unit performing bioavailability and bioequivalence studies as well as bioanalytical sample analysis, clinical laboratory and pathology services. Clinsys ALTERNA(TM) (clinsysalterna.com), a division of Clinsys Clinical Research, Inc., partners with clients globally to provide customized Phase I-IV clinical trial alternative solutions to the conventional outsourcing model. For more information, visit clinsys.com.

Contact

Mitchell Winfree

919.889.2992

mwinfree@clinsys.com

Clinsys, Clinsys Clinical Research, Inc., Clinsys GPS and Global Project Solution are registered trademarks of Clinsys Clinical Research, Inc. Clinsys ALTERNA registration pending. (C) Copyright 2008 Clinsys Clinical Research, Inc. All rights reserved.


'/>"/>
SOURCE Clinsys Clinical Research, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmatech Teams up With Systems Medicine LLC and the Sarcoma Foundation of America for a Phase II Myxoid Liposarcoma Trial
2. Harris Corporation Teams with Cancer Treatment Services International to Advance Oncology Treatment
3. Michael J. Fox Foundation Awards Up to $3 Million to Industry Teams to Jumpstart Promising PD Drug Development
4. National Wrestling Coaches Association Teams Up With CSG/SportsCoatings(TM)
5. Three Dimensional Visualization of Right Ventricle Provides Important Information for Treatment of Patients with Tetralogy of Fallot, According to a Study in The American Journal of Cardiology
6. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
7. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
8. Monogram Biosciences Provides Progenics Pharmaceuticals with HIV Assays for Use in Clinical Trials
9. Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pipeline Update
10. Stem Cell Research Provides Medical Breakthrough to Repair Heart Cell Damage Created by a Heart Attack
11. Indevus Pharmaceuticals Provides Update on PRO 2000 Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... For hospitals considering enrollment in the Federal ... the program, the Health Resources and Services Administration,s (HRSA) ... Mega-Guidance , could have significant impact on plans and ... 2016. Essential Insights , Daniel Neal, ... the Mega-Guidance,s key proposed changes, including a new requirement ...
(Date:2/4/2016)... 2016  SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN ... into a settlement agreement with the United States ... SEC,s investigation into possible violations of the Foreign ... the settlement agreement, SciClone has agreed to pay ... interest and a penalty.  This payment is in ...
(Date:2/4/2016)... LONDON , Feb. 4, 2016 ... Identifying and Commercializing First-in-Class Innovation ... disorder associated with chronic inflammation of the airways ... of COPD symptoms make the disease one of ... cause of death in the world. COPD is ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... , ... In sleep, when the defenses of the day are at rest, ... with eating disorders is significant self-criticism, and consequently these patients experience this disease with ... maladaptive means for coping with this unease, but also leads to a reservoir of ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... practical mobile kitchens, recently announced the debut of their latest mobile kitchen model, ... Kitchens provides organizations with modern, high-volume commercial kitchens for use anywhere in the ...
(Date:2/5/2016)... Moscow, Russia (PRWEB) , ... February 05, 2016 , ... ... update has a completely new user interface design and the developer has fixed known ... with those they want to on their phone while not consuming any of their ...
(Date:2/5/2016)... ... , ... –This week, Atascadero water heater company First Call Plumbing ... view the report, click here or see below. , There are ... and cons, the type chosen is almost entirely up to personal preference. However, tankless ...
(Date:2/5/2016)... ... ... tired of trying to cram belongings into spare space that just isn’t there, a self-storage ... before hastily spending money on a unit, take these tips into consideration. , Self-storage is ... often not told when utilizing these services are some tips on how to use the ...
Breaking Medicine News(10 mins):