For a number of years we had a client that helped small medical device manufactures setup and conduct trials for their devices. The Hightower Group has hired to create the software to enter and manage the data collected in these trials. Over the years we created both Windows based and Web based software. Each trial so so unique we had to create a separate program for each trial.
Key Improvements: In this case we where creating one off custom software system for each trail. The one major improvement was our cost to create the software was a quarter as much as their previous contractor.
The items was had to keep track of:
- Trial Subjects
- Various Forms for each Trial Subject
- Drugs the Subjects Used
- Adverse Events during the trial
- Validation Rules for each form.
- An Audit trail of all changes ever made to every form.
- Various Reports statistical reports
- Automatic Data Export
- Automatic Export Documentation.
This is not something you can just buy off the shelf. Each trial is unique and needs a custom solution to handle the requirements.