BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Proteonomix, Inc. (PROT) Announces Finalizing ECRF for Its Clinical Trial of UMK 121 in Patients With End Stage Liver Disease


10/26/2012 10:45:25 AM

PARAMUS, N.J., Oct. 26, 2012 /PRNewswire/ -- PROTEONOMIX, INC. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that the University of Medicine & Dentistry of New Jersey (UMDNJ) in conjunction with the Company and Numoda Corporation had finalized its Electronic Case Report Form for use in its clinical trial of UMK-121.

A case report form (or CRF) is a paper or electronic questionnaire (ECRF if electronic) used in clinical trial research. The ECRF is the tool used by the sponsor of a clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the ECRF, including adverse events.

The sponsor of the clinical trial, in this case Proteonomix, develops the CRF to collect the data needed to test their hypotheses or answer their research questions. The size of a CRF can be up to hundreds of pages of electronically captured data obtained over a period of weeks or months.

The sponsor or its designee is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in ECRFs. Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. The supervising Institutional Review Board (IRB) oversees the release of any personally identifiable data to the sponsor.

From the sponsor's point of view, the main logistic goal of a clinical trial is to obtain accurate ECRFs. However, because of human and machine error, the data entered in ECRFs is rarely completely accurate or entirely readable. To combat these errors monitors are usually hired by the sponsor to audit the ECRF to make sure the ECRF contains the correct data.

Michael Cohen, Proteonomix CEO noted: "The completion of the ECRF is one more step toward the commencement of the UMK-121 study."

About Proteonomix, Inc.

Proteonomix is a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives. The Proteonomix family of companies includes Proteoderm, StromaCel, PRTMI and THOR Biopharma. Proteoderm is a wholly owned subsidiary that has developed an anti-aging line of skin care products. StromaCel develops therapeutic modalities for the treatment of cardiovascular disease and for treatment of patients who have suffered post-myocardial infarction. Proteonomix Regenerative Translational Medicine Institute, Inc. (PRTMI) intends to focus on the translation of promising research in stem cell biology and cellular therapy to clinical applications of regenerative medicine. Additional information is available at www.proteonomix.com and www.proteoderm.com.

Forward-looking statements:

Certain statements contained herein are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Proteonomix, Inc. cautions that statements made in this press release constitute forward-looking statements and makes no guarantee of future performance. Actual results or developments may differ materially from projections. Forward-looking statements are based on estimates and opinions of management at the time statements are made.

SOURCE Proteonomix, Inc.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->