Spotlight On:
Data Management
Many of our clients turn to AlcheraBio for data management to support their pivotal and post-marketing studies. We’ve developed a proprietary, purpose-built data management system customized to meet the needs of the animal health community. The system utilizes a double data entry program with an audit trail, secure off-site backup, and other critical features. It features an easy system for generating queries and cleaning the data. Alexander Greenberg, MS, our full-time in-house IT manager and SAS programmer, can prepare listings and tables, program edit checks, create derived data sets, generate efficacy and safety summary reports, produce graphs, and design layouts for Final Study Report tables. Mr. Greenberg has experience in numerous aspects of software development as well as programming- and data-related clinical trial development and support. He has a thorough understanding of the processes involved in planning and conducting clinical studies and the reporting functions related to clinical trials, as well as experience generating analysis data sets, tables, listings, and study reports including efficacy and safety. Mr. Greenberg has worked with Wyeth and Schering-Plough.
Data Management Q&A with Dr. Johnny Jacobsen, AlcheraBio COO
What were the most important considerations in developing and implementing AlcheraBio’s purpose-built data management system?
From our point of view at AlcheraBio, data management (DM) begins well before the first data point is entered in a database. So our definition of “data management system” is comprehensive. Data management involves the design of the case report forms (CRFs); the quality of the monitoring of a given study; the integrity of the data management plan; the programming, functionality, consistency, and ease of use of the system into which the data are entered; and ensuring that the final, locked database is accurate, complete, and of the highest quality.
One of the most important considerations was integrating the data management with the monitoring of clinical trials so that these two functions support each other synergistically. After all, data quality is highly dependent upon ensuring that data captured in the field on CRFs are “translated” to electronic form – the database – as efficiently and effectively as possible. Another key consideration was building in quality control (QC) during the actual data entry process, to avoid incurring additional time to QC data post entry and to minimize quality assurance (QA) issues upon completion of data entry prior to database lock.
What are some of the features and benefits of the program?Some of the key features and benefits of the DM program are as follows:
- password protection and limited access to ensure confidentiality
- web-based system that allows easy access by authorized personnel
- double data entry that permits real-time identification and notification of entry errors on either first or second entry of data and immediate QC of the data
- programmed edit checks that identify illogical or missing data and generate appropriate queries automatically
- rapid resolution of queries generated during medical review of clinical data
- audit trail reflecting all changes to entered data, which enables identification and resolution of data entry issues by QA
- easy transformation of the database to SAS to facilitate statistical analyses of the data
Speed to market is the most important competitive advantage a client can have for a product, so reducing the amount of time between the end of a study and approval of a product or an additional indication is extremely important. Minimizing the time from last-patient-out (LPO) to database lock can decrease the time to filing and approval and is highly dependent upon resolution of queries and final data entry. The AlcheraBio DM program reduces the number of queries generated and the resultant QC/QA issues and allows database lock to occur expeditiously.
Within the confines of confidentiality, can you give an example of a project for which the program has been used?
We have just completed a significant clinical study for which AlcheraBio was responsible for the entire DM aspect of the study and for which the purpose-built DM program was utilized. The program was integral in delivering a locked database only 12 weeks after LPO.
Is the program compatible with electronic data capture and, ultimately, with electronic submissions?
The data management system has been designed to be compliant with the majority of the requirements of 21 CFR Part 11. AlcheraBio is undertaking a complete validation of our data management program to ensure compliance with 21 CFR Part 11. This will facilitate the submission of data electronically to regulatory agencies when electronic submissions become the norm. Furthermore, the program has been designed to allow incorporation of electronic data capture in future studies.
What if a Sponsor or client already has a study underway or wishes to monitor a study with internal resources? Can AlcheraBio’s data management system be used?
Certainly. We have clients who utilize our data management services on an “a la carte” basis. In those instances of course we prefer to become involved as early in the process as possible and we ensure that there are strong lines of communications with the client.
Yes. Our data management program lends itself very well to non-pivotal as well as pivotal studies.