Clinpro Offers an Advanced Data Management Platform That Efficiently and Cost Effectively Combines EDC and Paper Within the Same Trial

ClinPro’s ClinPlus® Data Management (CPDM) goes global! Now you can combine Web-based remote data acquisition (eRDA) with paper or fax within one system. This unique platform provides unparalleled flexibility, allowing sites and sponsors to choose the data transmission method that best meets their needs in an
efficient manner.

Web-based Remote Data Acquisition (eRDA)
Acquiring clinical data is difficult enough. Assuring the accuracy and completeness of that data only adds to the challenge. It is generally recognized that Web-based EDC, coupled with the right process, can achieve this goal. However, not all investigators are equipped or able to commit to EDC as a single data acquisition modality.

Now There’s a Simple Solution That Gives You Access from Anywhere Worldwide
With the ClinPlus® Data Management (CPDM) system, ClinPro now offers a unique solution. CPDM’s dual approach enables you to combine eRDA with paper or fax within one system. There’s no need to define multiple modalities, resulting in increased cost, complex logistics and longer setup time. Moreover, you’ll have the means to acquire data remotely, since the eRDA system provides secure access to the CPDM system from anywhere via Citrix® application deployment software. The authorized remote user can log into the CPDM system and enter data into case report form (CRF) look-alike screens.

ClinPro’s eRDA offers a fully validated, secure and cost-effective remote EDC application with advantages unmatched in the industry. For instance, a site that is unable or unwilling to use eRDA can either send in a paper CRF or fax the CRF to our data management facility for entry or Optical Character Recognition (OCR). All Clinpro data capture methods are integrated into a single system, using one process.

Ultimate Flexibility…No Need to Choose Between EDC and Paper!
Since eRDA is a menu driven remote portal to CPDM, you don’t have to commit to a decision on whether your trial will be paper-based or EDC. You can do it both ways, allowing investigators to choose the mode they are most comfortable with. Furthermore, if a site that initially chose to use eRDA decides to change to the traditional paper CRF mode, they can be easily switched without delays or additional costs.

Cost-effectiveness – One Process, One System, One Database!
ClinPro’s approach is based on a single process using a single data management system with a single SAS database at its center. Therefore, the ultimate flexibility in the choice of the data acquisition mode that ClinPro can offer its client does not come at an extra cost!

eRDA Does Not Require an Additional Application Setup — Just Use Your Hardware and Internet Connection
The decision to utilize an EDC mode in your trial does not require installation of a separate EDC system and payment of high licensing fees. All you need is an internet connection and a browser (which you most likely already have). Whether a study uses eRDA or the traditional paper data entry, it is set up in CPDM. Authorized study-site personnel receive unique user IDs, passwords, authorization level appropriate to their function and they are ready to go. The system is 21 CFR Part 11 compliant.

Sophisticated Remote Data Acquisition and Editing Capability – Get Clean Data the First Time!
The site study coordinator will navigate through the data entry screens in a logical and intuitive fashion. Hard and soft edit checks programmed into the screens will prevent the entry of invalid data. The study coordinator will be automatically alerted upon the entry of inconsistent data or when selected protocol requirements are violated. In addition, the study coordinator can see data queries that were posted by the monitors or data managers and take corrective action, resolving the queries and updating the database immediately.

Data Browsing, Documents and Reports
With security authorization, users can view and browse the entire clinical study database or selected study sites data from their desktop. With a click of the mouse your sponsor, monitor or investigator can have access to important study documents and execute real-time reports from anywhere.