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