Aeris Therapeutics: Attainable, knowledgeable Assistance
ChallengeLocated in Massachusetts, Aeris Therapeutics (“Aeris”) specializes in developing non-surgical treatments and medical devices for patients with lung disease. Just last year, this privately held organization was granted a fast track designation from the FDA for its program to develop medications for emphysema. Doubling in size this year, Aeris Therapeutic has hired thirty-two new associates since its inception five years ago.
As with most organizations in this niche market, clinical departments desire full and immediate assistance with their clinical systems; a task which is quite challenging for most internal information technology divisions to supply. BioPharm Systems was referred to Aeris Therapeutics from associates in the business. It was BioPharm’s expertise in Oracle Clinical Database Management Systems (“Oracle Clinical”), Oracle Thesaurus Management Systems (“Oracle TMS”) and Validation Engineering work that sold Aeris to hire BioPharm to join into her project team.
Solution
Full range of services to both complete the project and allow for future trial success
BioPharm Systems came with their Senior Consultants to get the project underway. This implementation project required full installation and upgrades of the systems in addition to complete IQ, OQ, and PQ validation executions. Aeris further extended our services to include the purchase of our Standards of Procedures guidelines to ensure policies and regulations were in place. Once Oracle Clinical and TMS were installed and fully tested, BioPharm worked with Carol Becker, Manager of Data Management to setup the first pilot test. This service allows both the client to experience how to use the systems within a real-world application as well as quickly kick-off the first trial, reaping the benefits of the new system. As with all projects, our Help Desk support is available both during and after implementation to ensure a smooth transition. Our consultants as well as the Aeris Clinical team utilized this service during the project implementation. To further enhance knowledge transfer, Aeris opted for the Oracle Clinical Basics training in addition to Oracle TMS training courses which were taken at our in-house training center in San Mateo, California.
Results
With all the services, the project was completed on time for their next clinical trial to begin. Mrs. Becker enjoyed the working with our consultants. She stated that even though on a few consultants were assigned the assignment, they did the work a full-blown team, greatly helping to keep the price down for such a small healthcare organization. She highly recommends using BioPharm Systems for IT Clinical System needs and plans to use our company again in the future.
