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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
CDC Updates Zika Recommendations
CDC has issued updated Zika recommendations and guidance for healthcare providers with a focus on sexual transmission.
Review of the Analysis of Haemoglobin A1c for Diabetes Diagnostics
This paper aims to clarify methods, units, quality requirements, reference and cutoff limits for hemoglobin A1c (HbA1c) and ratio of blood glucose/HbA1c on the basis of the results from Finnish quality control surveys by comparing them to the literature.
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Drug - Gene 'One-Two' Punch Against Cancer
Researchers identify gene-drug combinations that, together, target and kill cancer cells while not targeting healthy cells.
Liquid Biopsies Treating Ovarian Cancer
Researchers have discovered a promising monitor and treat recurrence of ovarian cancer. Detecting cancer long before tumours reappear.
72% Rise in Metastatic Prostate Cancer
Over the 2003-2013 period metastatic cancer has increased by an average of 72%, this could be caused by lax screening, more aggressive disease or both.
Lab-Tested Diagnosis Needed When Treating Persistent Diarrhea
New PCR multiplex method makes lab testing more effective.
Biomarker for Multiple Sclerosis Detection Discovered
Winthrop-University Hospital researchers discover biomarker for multiple sclerosis detection.
Scientists Link Bipolar Disorder to Unexpected Brain Region
Researchers from The Scripps Research Institute have found that gene within the brain’s striatum could be linked to biopolar disorder.
SELECTBIO

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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!