Phase II - IV Clinical Development

At QPS, we realize that in today's late stage drug development space you face many challenges:

  • Strict Timelines
  • Manage Increasing Amounts of Clinical Data from Multiple Sources and Systems
  • Insufficient Trial Populations

With our global presence, QPS is in an excellent position to offer solutions to all of the above needs. QPS provides high quality data, industry best timelines and a very competitive price. We also have access to a large network of investigators for all major types of therapeutic categories.

With its site management & monitoring teams operating from three different continents (Asia/Pacific, USA and Europe), QPS has become a new strong player in the space of late stage clinical research services. Widely recognized for achieving high-quality study data and high patient enrollment rates, QPS' site management & monitoring teams bring years of experience catering to the unique needs of virtual, small, mid-size and large pharmaceutical and biotechnology firms.

Global Sites

Beijing, China
Graz, Austria
Groningen, The Netherlands
Hyderabad, India
La Coruna, Spain
Miami, FL, USA
Munich, Germany
Newark, DE, USA
Osaka, Japan
Prague, Czech Republic
Seoul, South Korea
Shanghai, China
Springfield, MO, USA
Taipei, Taiwan
Zagreb, Croatia

Phase II - IV Clinical Development Leadership Team

Brock Guernsey
Brock G. Guernsey
VP and Global Head of Clinical Research Services
David
David Hsu
Director of Clinical Research Department
ChauHwei
ChauHwei Fu
Director of Clinical Research Services
Jan Bart Hak
Jan Bart Hak
Division Director of Clinical Research
K
Kelle Simpson
Director, Project Management
Ard Vink
Ard Vink
Director Clinical Operations Late Phase

Project and Program Management

QPS's Late Stage Study Management Group takes care of all documentation required for your clinical studies, according to your own or QPS’s SOPs. Our study managers ensure a timely handling of activities for clinical studies, such as submissions to ECs and/or competent authorities and coordinate the clinical teams for conducting the studies. The appropriate investigational sites for your clinical studies can be selected by QPS’s study managers and they can assist the centers in recruiting patients. Furthermore, they will be in close communication with you to keep you well informed about the status and progress of your clinical studies.

Study Monitoring

The Study Monitoring Group at QPS consists of well trained and experienced CRAs who conduct site management and monitoring according to the applicable guidelines and laws. They have vast experience in monitoring clinical studies for new pharmaceutical compounds and medical devices. The monitoring services will be conducted exactly according to your requirements. Our CRAs can be located at your site, or can work from QPS' local offices.

Clinical Trial Logistics

QPS ensures that all your study material is timely available at the appropriate locations. The logistical support includes preparation and shipment of sample tube kits, shipment of clinical samples, documents, medication and or medical devices to and from the clinical investigational sites.

Data Management

QPS' Data Management Group support the conduct of your clinical trials from case report form design to the timely release of a clean, high quality study data base. This is performed using Oracle™ Clinical or OpenClinica as principal tools.

Biostatistics

QPS’ Biometrics group support the conduct of your clinical trials with the timely delivery of clean, high quality Tables, Listings and Figures. This is performed using SAS as principal (validated) software tool.

Medical Writing

The quality of written clinical presentations plays a critical role in the success or failure of new compounds and devices. The medical writing group at QPS can help you produce a wide range of medical or scientific documentation. By turning the fruits of your scientists’ research into well written documentation, QPS enables your staff to focus on what they are good at: developing new drugs and devices.

Scope of services
  • Study protocols and reports (Phase I-IV) 
  • Abstracts, manuscripts and journal articles
  • Investigator brochures and annual updates 
  • Informed consents
  • Response to clinical hold orders
  • Pre-clinical study reports, expert reports and summaries 
  • Data Safety Monitoring Board (DSMB) manuals 
  • Benefit risk assessment reports 
  • Non-clinical ADME reports 

Therapeutic Expertise

QPS has broad experience across phase I-IV clinical development in a wide range of therapeutic indications handling both drug, diagnostic and device trials, and contributing to numerous product approvals since our founding in 1995.

We have the most notable depth and breadth of late phase clinical expertise in the following top-tier indications:

 
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CNS Disease Alzheimer’s Disease Brochure New Draft FDA Guidelines for Alzheimer´s Disease: Which Cognitive Testing Battery Guarantees Success? - May, 2013
QPS CNS Drug Development Whitepaper Serial CSF Sampling for PK and Biomarker Analysis - April, 2013
Imaging Methods for Alzheimer’s Disease - March, 2013
Serial CSF Sampling over a Period of 30 h via an Indwelling Spinal Catheter in Healthy Volunteers: Headache, Back Pain, Tolerability and Measured Acetylcholine Profile - March, 2013
Amorfix and QPS to Collaborate on Alzheimer's Disease Project - January, 2013
Endocrinology Diabetes Brochure Doug Kalman, Director of QPS MRA’s Nutrition/Endocrinology Department publishes Article on the Amino Acid Composition of Concentrated Protein Powders - August, 2014
Oncology Oncology Brochure Eric Solon Co-presents Poster at AACR (American Association for Cancer Research) Annual Meeting showing the Tissue Disposition Profile of a 2nd Generation Hypomethylating Agent - April, 2014
QPS Antibody Drug Conjugates Whitepaper ERK1/2 activation as a tractable biomarker during clinical evaluation of BRAF inhibitors and other inhibitors of the ERK1/2 pathway - July, 2012
Neurology Pain Management Brochure Postoperative Cognitive Dysfunction (POCD) - April, 2013
Respiratory Respiratory Brochure QPS Respiratory & Allergy News - August, 2014
QPS Respiratory & Allergy News - February, 2014
QPS Engages in International Collaboration for Innovative Respiratory Research - November, 2013
Sophisticated Biomarkers, Including Gene Expression Profiling from Nasal Brushings, Sputum and Blood, Are Used in COPD Therapy Trial - November, 2013
Summer Update from the QPS Respiratory Team - August, 2013
Using Biomarker Analysis on Induced Sputum as a Measure of Primary Outcome in Asthma and COPD - April, 2013
Infectious Diseases QPS Hepatitis C Whitepaper Howard Schwartz, Medical Director of QPS Miami Research Associates Co-Authors Daclatasvir-Sofosbuvir Combination HCV Trial Published in The New England Journal Of Medicine - February, 2014
Dermatology QPS Transdermal Whitepaper Paul Lehman, QPS’ Vice President and Head of Dermal and Transdermal Research publishes Article on Assessing the Relative Bioavailability of Topical Clobetasol Propionate Products - August, 2014
QPS Dermal & Transdermal Brochure A randomized, double-blind, placebo-controlled clinical trial evaluating Dermytol® cream for the treatment of actinic keratoses
Paul A. Lehman, QPS’ Vice President and Head of Dermal and Transdermal Research Co-authors Book Chapter on Establishing the Bioequivalence (BE) of Topical Drug Products - February, 2014
QPS Announces Paul A. Lehman as New Vice President of Dermal and Transdermal Research Services - June, 2013
Female Healthcare QPS Female Healthcare Brochure Pharmacokinetics of fingolimod (FTY720) and a combined oral contraceptive coadministered in healthy women: drug-drug interaction study results

 

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