BioPortfolio Special Bulletin
http://www.bioportfolio.co.uk/bulletin_special_16.htm 

QualityMetric Clinical Trials Consulting Team: Strength of Evidence
http://www.qualitymetric.com/home.html?mailing_id=7

Pharmaceutical companies and Contract Research Organizations (CROs) around the globe turn to QualityMetric’s Clinical Trials Consulting Team for the:

  • Selection and Development of patient-reported outcomes measures in all phases of drug/device development and testing
  • Design of clinical trials, data collection protocols, and analytic plans
  • Analyses and re-analyses of clinical trials data and interpretation of results
  • Preparation of abstracts, presentations, and manuscripts reporting results

QualityMetric is the leading developer and provider of generic and disease-specific health outcomes surveys.  But even with the best available patient-reported outcomes and supporting documentation, clients find QualityMetric’s consulting advantageous when it comes to explaining results and justifying conclusions. With over three decades of experience in the development and application of patient-reported health outcomes for clinical trials, QualityMetric’s Consulting Team can be a determining factor for companies seeking FDA approval.

For more information on QualityMetric's Clinical Trials Consulting Team:

http://www.qualitymetric.com/products/Consulting.shtml 

Or e-mail us at consulting@qualitymetric.com

How Can QualityMetric’s Clinical Trials Consulting Team Assist Your Company?

With many drugs in the discovery and development pipeline holding the promise of reduced health impact from chronic diseases and conditions, QualityMetric’s Clinical Trials Consulting Team can assist by providing clients the following services and benefits:

Consulting Service

Client Benefit

SF Literature Review: Summary of published articles referencing use of SF tools in your therapeutic area

·     Establish usefulness of SF surveys in key therapeutic areas

·     Review published treatment effects as benchmark for evaluation

·     Saves staff time and ensures depth and breath of research through QualityMetric’s extensive SF literature database.

Evaluate data quality and scoring

·     Confirm integrity, reliability, validity of health-related quality of life (HRQOL) data

·     Correct database for errors in survey administration or scoring

·     Impute missing data using tested, proven algorithms

Burden of disease analysis: Norm-based interpretation of HRQOL scores at baseline

·     Quantify the HRQOL burden of disease and unmet need for treatment

·     Compare baseline HRQOL scores to condition-specific or population norms

Norm-based interpretation of treatment effects

·     Compare HRQOL treatment effect size to published estimates using a standardized measurement metric

·     Quantify reduction in HRQOL burden of disease after treatment

·     Compare post-treatment HRQOL scores to condition or population norms

Evaluate reliability/validity of new or modified patient-based outcomes measures

·     Assert that measurement tools used in clinical trial are responsive enough to detect the treatment –induced improvements in patient’s lives

·     Establish a sound basis for interpreting results

·     Ensure comparability of translated HRQOL tools for use in multi-national trials

Prepare manuscripts for publication in leading peer-reviewed journals and provide results presentations to client or at major national conferences

·     Share research results with the world through conference venues and publishing in leading peer-reviewed journals

QualityMetric Clinical Trials Consulting Team: Strength of Evidence

QualityMetric has recruited some of the most experienced and respected scientists with interest in real-world applications to consult on science-based solutions for pharmaceutical companies and CROs who need practical and precise measures for risk screening and outcomes monitoring. Our experience includes:

·     Partnerships with pharmaceutical companies yielding FDA approval based on clinical trial results that included HRQOL

·     Salvaging trial data and uncovering treatment efficacy overlooked by internal clinicians and analysts

·     Use of QualityMetric’s exclusive computer adaptive survey technology for “landmark”, large-scale open label clinical trials

If you’d like to review the qualifications of our Science and Consulting Team:

http://www.qualitymetric.com/company/management.shtml

For information on any QualityMetric product or service, visit us at: www.qualitymetric.com or e-mail consulting@qualitymetric.com

If you can improve health care, QualityMetric will help you prove it.

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