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Pre-clinical and Phase 0 Data Collection and Management - Overview

As you know, the foundation of any investigational treatment starts with in vitro or in vivo experiments and human microdosing studies. Further development will not take place unless preliminary efficacy and toxicity information is obtained through accurate and properly organized research data. DDA Medical can provide you with efficient and reliable data collection tools you need for pre-clinical studies and Phase 0 clinical trials. Through a single Internet-based tool, investigators, laboratories, and research centers can communicate on experiences, submit reference data and outcomes, and manage forms to streamline the development process so that the next stage is more quickly realized.

Pre-clinical and Phase 0 Data Collection and Management - In-depth

The foundation of any investigational treatment starts with in vitro or in vivo experiments and human microdosing studies. Further development will not take place unless preliminary information is obtained through accurate and properly organized research data. DDA Medical can provide you with the efficient and reliable online data collection and management tools you need for pre-clinical studies and phase 0 clinical trials. Through a single Internet-based tool, investigators, laboratories, research centers, and sponsors can communicate on experiences, submit reference data and outcomes, and manage forms to streamline the development process so that the next stage is more quickly realized.

 

Data Collection and Management in Pre-clinical Studies

Proper data collection and management during pre-clinical studies is extremely important. At the study’s conclusion, you’ll need to submit your data for review by the Food and Drug Association (FDA) in order to receive investigational device exemption (IDE) or premarket approval (PMA) for clinical trials. If data is missing or inaccurate, your submission to the FDA may require that you go back to the lab or even start over. At DDA Medical, we’ll work with you to develop an online clinical data management system so that all predetermined parameters – such as histology, clinical pathology and angiography – are accounted for in one seamless software program and information is easily accessible to those granted permission. Our eClinical trial data management solutions improve data collection and analysis capabilities available to the sponsoring company and researchers working with animals in the laboratory environment.

 

Data Collection and Management in Phase 0 Clinical Trials

Phase 0 studies, designed to gather preliminary information on the human’s physiological response to the administration of subtherapeutic doses, can be invaluable in clinical trial research and development. Focused on tolerance and the ability to “hit a target”, phase 0 studies enable sponsors to make go/no-go decisions on whether to continue testing of a particular agent. Obtaining comprehensive and accurate biochemical, metabolic, and pharmacologic data is critical in providing justification for such decisions. Furthermore, off-target data can be collected in the discovery of other treatment possibilities and patient data can be managed for investigators who advocate that their patients receive treatment after the phase 0 experience has ended and he or she wishes to undergo another clinical trial. DDA Medical can produce the eClinical trial technologies that provide the data management solutions you need to gather all information in one secure online resource hosted on our HIPAA-compliant servers. Our proprietary software can be tailored to your clinical trial model, making the development process seamless, so that the next phase can be expedited, getting one step closer to FDA approval and advancing treatment options for patients who need them most.