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Clinical Research
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Don Ramage was responsible for coordinating activities for a enterprise wide contact management system, including; RFI, RFP, vendor selection for the new content management system. The content management system was designed to manage all of a fortune 100 pharmaceutical clinical SBU(strategic business unit) electronic images (eCRF) associated with clinical case studies, used for submissions to the FDA and tracking and recording adverse events.
Don was responsible for the prototype design of a tactical skill assessment tool. The tool is designed to assess c-level management and their knowledge and skill preparedness associated with key milestones throughout a drug product SDLC.
Don was responsible for the prototype design of a tactical skill assessment tool. The tool is designed to assess c-level management and their knowledge and skill preparedness associated with key milestones throughout a drug product SDLC.
eCRFs let physicians, researchers and their staff capture the data of research subjects (e.g. in medical drug testing) to be acquired specifically and individually and to analyze them in a standardized manner. The objective is to streamline the many individual steps in a study while at the same time satisfying international regulatory and statutory requirements.
Online electronic data acquisition is extremely fast - and less error-prone, thanks to integrated plausibility checks. The automated transfer of data from measuring instruments and data acquisition systems greatly reduces the effort of data acquisition, and it helps avoid data entry errors. Quantitative and qualitative statements may be made at any point of the study - even as data acquisition is still in progress.
This means that the study designers can react to current findings on the spot and - for example - modify treatment and examination parameters as the study is being conducted. The results of these modifications can itself be examined on an ad-hoc basis.
It is now possible to cut the time from entering the last patient data (Last Patient Out) to closing the database from an average of four months (!) in conventional paper-based research documentation - to as little as 48 hours.
This enormous time saving is made possible by concurrent processing of data acquisition, query management, and data consistency checks as well as centralized online data storage.
Electronic Case Record Form which is the hart of the system.
Capture, manage, and integrate study data while ensuring protocol compliance, and data accuracy and integrity
Online electronic data acquisition is extremely fast - and less error-prone, thanks to integrated plausibility checks. The automated transfer of data from measuring instruments and data acquisition systems greatly reduces the effort of data acquisition, and it helps avoid data entry errors. Quantitative and qualitative statements may be made at any point of the study - even as data acquisition is still in progress.
This means that the study designers can react to current findings on the spot and - for example - modify treatment and examination parameters as the study is being conducted. The results of these modifications can itself be examined on an ad-hoc basis.
It is now possible to cut the time from entering the last patient data (Last Patient Out) to closing the database from an average of four months (!) in conventional paper-based research documentation - to as little as 48 hours.
This enormous time saving is made possible by concurrent processing of data acquisition, query management, and data consistency checks as well as centralized online data storage.
Electronic Case Record Form which is the hart of the system.
Capture, manage, and integrate study data while ensuring protocol compliance, and data accuracy and integrity
