Data Management

AlcheraBio has developed a proprietary data management system specifically for use in animal health studies. The AlcheraBio system covers all aspects from planning through to delivery of a locked database converted to SAS data files and ensures confidentiality and security.

Alexander Greenberg, MS, our full-time in-house IT manager and SAS programmer, 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.

He prepares listings and tables, programs edit checks, creates derived data sets, generates efficacy and safety summary reports, produces graphs, and designs layouts for Final Study Report tables.

Key elements of the AlcheraBio data mangement system are described below:

  • A detailed data management plan for each study is developed in consultation with the Sponsor and approved in writing by the Sponsor. The plan includes procedures for data entry, medical review, query generation, data filing, and QC, as well as transfer of central lab data, edit checks, QA, and transfer of the database to SAS.
  • A study-specific database is designed for each study, and fields are mapped from the study case report forms to the database.
  • After review by the monitoring staff, typically at the study site, data recorded on the case report forms are entered into the database at the AlcheraBio office. All data entry personnel are trained on each study protocol and the related data entry templates.
  • A double data entry program which features an audit trail and query generation. Following resolution of all inconsistencies arising from the double data entry process and medical review, QA personnel perform an audit of the database against the raw data.
  • The database is easily transformed to SAS files to allow for study specific descriptive statistics and tables and data listings.
  • Database files are password protected to ensure confidentiality, automatically backed up each day, and stored offsite.

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? At AlcheraBio, data management (DM) begins well before the first data point is entered in a database. So the 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
What makes the program cost-effective for AlcharaBio’s clients? 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?
AlcheraBio has just completed a significant clinical study for which AlcheraBio was responsible for the entire DM aspect of the study. 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. AlcheraBio has clients who utilize our data management services on an “a la carte” basis. In those instances of course the preference is to become involved as early in the process as possible to ensure that there are strong lines of communications with the client.

Is AlcheraBio’s data management program available to clients who have commissioned studies that aren’t pivotal studies, such as post-marketing (Phase 4) studies? Yes. The data management program lends itself very well to non-pivotal as well as pivotal studies.

For more detailed information on AlcheraBio’s data management system, click here.