Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Theorem Clinical Research Distributes Clinical Trial Advice

Published: Thursday, February 28, 2013
Last Updated: Thursday, February 28, 2013
Bookmark and Share
Company releases booklets to provide ICH GCP guidance for in vitro and investigational product trials.

Theorem Clinical Research has released two site-level reference booklets for clinical research sites that explain and condense critical International Conference on Harmonisation guidelines related to Good Clinical Practice for the conduct of trials.

Authored by Judith Köhnen and Lee Spurgin, PhD, “Little Advisor ICH GCP for Investigational Product Trials” explains key concepts of the ICH GCP requirements. Their second book, “Little Advisor ICH GCP for In Vitro Diagnostic Trials,” provides guidance on regulations specific to trials involving in vitro diagnostic devices. Both are available for purchase online.

Spurgin, senior vice president for medical device and diagnostic development, and Köhnen, senior project director for medical device and development, have years of experience with the conduct of clinical trials. Both manuals cover topics such as qualifications, regulatory authorities, ethics committees, the informed consent process, safety reporting and more. The information, presented in an easy-to-read format, highlights and explains critical information and provides practical advice.

“We developed these booklets to help investigators better understand the guidelines that govern clinical trials,” said Spurgin. “The guidelines themselves are lengthy and sometimes confusing. These manuals are an accessible resource for clinical research sites.”

A third booklet, previously released by Theorem, has been popularly received by sites seeking to understand the International Organization for Standardization’s requirements for medical device trials. “Little Advisor ISO 14155:2011 for Medical Device Trials” is also available online.

All three booklets provide full citations back to the original ISO or ICH GCP documents for those who need more detail. And, all the topics in the original document are included in the respective booklets.

Theorem Clinical Research’s reputation comes from years of focused experience in managing complex studies. By bringing together teams of clinical, regulatory and study management experts, Theorem provides innovative development programs across the entire spectrum. The company has the development and regulatory expertise to execute successful trials across all risk classifications and approval pathways globally. Theorem’s regulatory and health economics experts also develop adjunctive reimbursement and safety surveillance programs and provide ongoing marketing support.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Heart Arrhythmia Caused by Mosaic of Mutant Cells
Researchers have solved the genetic mystery of an infant suffering from heart arrhythmia.
Crispr Toolbox Expanded By Protein
Researchers have shown a newly discovered CRISPR protein has two distinct RNA cutting activities.
Over Two-Thirds of Cervical Cancer Deaths Prevented
Cervical screening prevents 70% of cervical cancer deaths and if all eligible women regularly attended screening this would rise to 83%.
Detecting Bacterial Infections in Newborns
Researchers tested an alternative way to diagnose bacterial infections in infants—by analyzing RNA biosignatures from a small blood sample.
Mechanisms of Parkinson’s Pathology
Defects that lead to cells’ failure to decommission faulty mitochondria cause nerve cells to die, triggering the symptoms of Parkinson’s disease.
Case for Liquid Biopsies Builds in Advanced Lung Cancer
Study addresses unmet need for better, non-invasive tests called out in recent "Moonshot" blue ribbon panel report
Genetic Misdiagnoses of Heart Condition
Analysis found several genetic variations previously linked with a heart condition were harmless, leading to condition misdiagnosis.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Genetic Diversity of Enzymes Alters Metabolic Individuality
ToMMo scientists have shown that genetic polymorphisms, structural location of mutation and effect for phenotype correlate with each other.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!