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 — 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.
