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Premier Research Group Ltd

Premier Research Group Ltd
1st floor, Rubra 2
Mulberry Business Park
Wokingham
United Kingdom
Phone: 44 118 9364000
Fax: 441-18-9364001
www.premier-research.com

Turnover: 27.17 (US$m)
Financial year end: December

Company Overview

Top Competitors


Key Employees

Ludo Reynders

Chief Executive Officer, Senior Management

Sean Russell

Chief Commercial Officer, Senior Management

Charlie Nicholson

Chief Financial Officer, Senior Management

Simon Britton

Chief Operating Officer, Senior Management

Krista Armstrong

Vice President - Strategic Development, Senior Management

Joanne Emmett

Vice President - Medical Devices, Senior Management

Colin Hayward

Chief Medical Officer, Senior Management

Angi Robinson

Director - Pediatrics and Rare Disease, Senior Management

Shari V. Medendorp

Senior Vice President - Biometrics, Senior Management

Michael Kuss

Vice President - Analgesia, Senior Management

Ajay Sadhwani

Vice President - Clinical Operations, Senior Management

Bassem Saleh

Vice President - Medical Affairs, Senior Management

Keith Fine

Vice President - Functional Services, Senior Management

Dora Alvarado

Vice President - Human Resource, Senior Management

Nicky Dodsworth

Vice President - Global Quality Assurance, Senior Management

Lisa Pitt

Vice President - Global Regulatory Affairs, Senior Management

Michael King Jolly

Senior Vice President - Strategic Development, Senior Management

Gaurav Sharma

Vice President, Head - Global Project Management , Senior Management

Nate Thompson

Chief Information Officer, Senior Management

Howard Welgus

Director, Senior Management

Carol Gaines M.D.

Senior Medical Director, Senior Management

Hallenbeck

Executive Director-Oncology, Senior Management

Susan Romberg

Senior Vice President - Clinical Operations, Senior Management

Nina Baluja

Senior Medical Director for Medical Services, Senior Management

Locations/Subsidiaries


1st floor, Rubra 2,
Mulberry Business Park,
Wokingham,
Berkshire,
United Kingdom
Phone: 44 118 9364000
Fax: 44 118 9364001

11 th Floor,
Infinity Tower,
Bulgaria
Phone: 359 2 4217000
Fax: 359 2 9331743

2425 Matheson Blvd. ,
ESTE 800,
Mississauga,
Ontario,
Canada
Phone: 1 905 3612897

Xaveriova 1900/10,
Czech Republic
Phone: 420 0 251101201
Fax: 420 0 251101202

29 rue Taitbout,
Paris,
France
Phone: 33 1 44501077
Fax: 33 1 40150198

1036 ,
Budapest,
Hungary
Phone: 36 1 4609816
Fax: 36 1 4609815

Via Winckelmann 2,
Milano,
Italy
Phone: 39 02 48958768
Fax: 39 02 48958776

Diplomat Business Center,
Sevastopol Street, No 13-17,
Romania
Phone: 40 21 3106537
Fax: 40 21 3106535

Office 527, Block 11,
3 Gostinichinaya Str,
Russia

Udernicka 5,
Bratislava,
Slovakia

37, Verkhovinna Steet,
1st Floor,
Kiev,
Ukraine
Phone: 380 44 5850248
Fax: 380 44 5850247

1st Floor, Rubra 2,
Mulberry Business Park,
Wokingham,
United Kingdom
Phone: 44 118 9364000
Fax: 44 118 9364001

234 Copeland Steet,
,
FLQuincy,
Massachusetts,
United States of America
Phone: 1 617 2371100
Fax: 1 617 2371101

387 Shuman Boulevard,
STE 340W,
Naperville,
Illinois,
United States of America
Phone: 1 630 8216218

Research Triangle Park,
One Park Drive, Suite 150,
Durham,
North Carolina,
United States of America
Phone: 1 919 6279069

Premier Research Australia Pty Ltd

Ground Floor, 23 Milton Parade ,
Malvern,
Victoria,
Australia

Premier Research LLC

Suite 3500,
1500 Market Street,
Philadelphia,
Pennsylvania,
United States of America
Phone: 1 215 2825500

Scirex Corp

437 Madison Ave ,
New York,
New York,
United States of America

Products/Services


Services:

  • IVRS/IWRS
  • Strategic Sourcing
  • Phase I Clinical Research
  • Phase II–III Clinical Research
  • Late Phase (Phase IV)
  • Medical Writing
  • Regulatory Affairs:
  • Regulatory Consulting
  • Regulatory Operations
  • Electronic Submissions/eCTD
  • United States Authorized Representative
  • EU Legal Representative
  • EU CTA Applicant
  • EU Registered Company for Marketing Authorization Applications
  • Regulatory Agency Liaison
  • Regulatory Due Diligence
  • Device Classification and Strategy
  • Critical Literature Review
  • CE Mark Process
  • Biostatistics:
  • Regulatory Statistical Consulting and Representation
  • Integrated Clinical/Statistical Development Programming
  • PK/PD Model Development and Analysis
  • Design and Analysis of Clinical Trials
  • Design and Analysis of Observational, Registry and Rx-to-OTC Switch Studies
  • Health Outcome, Pharmacoeconomic and Quality of Life Analyses
  • Large-Scale Data Warehousing and Integration
  • ISS/ISE Planning, Analyses and e-Submissions
  • Data Monitoring Committee Support and Participation
  • CDISC Compliant Dataset Development
  • Manuscript Preparation and Meeting Presentations
  • Marketing Support
  • Data Management:
  • Protocol Review
  • CRF Design and review (incorporating CDASH)
  • CRF annotation (conventional or SDTM compliant)
  • EDC consulting (experience with multiple database platforms and vendors)
  • Internal EDC capabilities using DataLabs (include R symbol) and Oracle (include R symbol) Clinical RDC
  • CRF scanning and tracking for paper studies
  • Database design, validation, and maintenance
  • Lab data management and normalization of units (conventional or SI)
  • Query management
  • Medical coding
  • Data quality assurance
  • SAE and external data source reconciliation
  • Real-time data access/browsing
  • Standard and Custom Reporting
  • Complete Data Operations Support for NDA Submissions
  • Medical Affairs + Consulting
  • Clinical Development Program Consulting
  • Medical and Scientific Support for Regulatory Submission
  • Protocol, Informed Consent, and CRF Design and Review
  • Investigator Brochure Development
  • Laboratory Data Review
  • Medical Data Review
  • Medical Coding
  • 24-hour Medical Monitoring
  • Data Monitoring Committee Coordination (DMC and DSMB)
  • Independent Review of Clinical Endpoint Committees Coordination
  • Regulatory Agency Support
  • Support for Pediatric Regulation Compliance
  • Physician-to-Physician Interface
  • Site Selection and Enrollment Enhancement Solutions
  • Key Opinion Leaders Networks
  • Publication Planning and Review of CSRs and Scientific Manuscripts
  • Pharmacovigilance:
  • Clinical trial pharmacovigilance
  • Post marketing surveillance
  • Device safety
  • Expedited and periodic reporting
  • QPPV
  • Literature reviews
  • 24-hour medical monitoring
  • Quality Assurance:
  • Investigative Site Audits
  • Trial Master File Audits
  • Database Audits
  • Clinical Study Report Audits
  • Statistical Report Audits
  • Vendor Audits