1. DRAFT PROTOCOL TO ECRF COMPLETION INCLUDING CREATION OF EDIT CHECKS AND UAT

In general, we can start working once we have a reasonable draft of the protocol as long as we agree that the majority of the navigation and forms will not change. As mentioned above, putting up the forms usually takes about a week, depending on the complexity of the study. The first study we perform together almost always takes a bit longer, but a week is a good estimate to display the forms. Form generation also goes much faster if protocols are similar. Programming of online edit checks usually takes another week plus a few days for documentation. Our final testing takes about 3-4 days. As a result, we usually plan 4 weeks from start to finish but we have been know to get a program up and running in 2 weeks. If the client does UAT, it could add up to a week for the process.

The only reason a release takes more than 20 work days is that the sponsor makes additional changes. We try never to be on the critical path.

From Ferring Pharmaceuticals:

"When both parties (Ferring and Target Health) are committed to setup a trial quickly, we have a KPI of app. 1-2 weeks. In this area, a typical time-frame is between 2-4 weeks, never exceeding 6 weeks."

From Regeneron Pharmaceuticals:

"Approximately 4 weeks" to get a study up an running.

2. LAST PATIENT LAST VISIT TO DATABASE LOCK
Here are unsolicited quotes from Ferring Pharmaceuticals:
"When both parties (Ferring and Target Health) are committed to clean file a trial quickly, we have here a KPI of app. 3-5 days. In this area, a typical time-frame is between 1-2 weeks, never exceeding 3 weeks."

"Congratulations for the clean file! Clean files are important milestones. Especially, when they are achieved in a record time and with all documentation so well-recorded (I guess both issues are usually linked). It should be acknowledged your enormous effort. It requires dedication and know-how to establish clean file just 8 days after the LPLV. I really appreciate your efforts, persistence, continued motivation and drive for excellence."

"As you surely know, we had database lock for our pivotal study CS21 10 days after LPLV and 3 days after last data available. This extraordinary achievement was doable thanks to all involved, including you. I wanted also to thank you especially for always going the extra mile for us whenever needed."

From Regeneron Pharmaceuticals:
"Approximately 4 - 5 weeks. Depends on the monitoring."

Target Health experience:
There is no question if the monitoring is good, database lock can occur within a week of the last monitoring visit. Our experience is 2-4 weeks.

3. DATABASE LOCK TO CREATION OF TABLES/LISTINGS/FIGURES

From Regeneron Pharmaceuticals:
"Approximately 1 week to draft TFLs. Final TFLs took about 3-4 weeks (one review cycle)."

Target Health experience:
We release draft TFLs within 2 days of database lock. Most of the time, we have reviewed the TFLs with the client with a dummy randomization code, so that are usually few changes after database lock. We usually finalize TFLs within 2-5 days of database lock. The only reason it would be longer is if the client changes their mind, which does happen.

4. DATABASE LOCK TO DRAFT CLINICAL STUDY REPORT.

From Regeneron Pharmaceuticals:
"We aim for 8 weeks. It can be more like 10-12."

Target Health Experience:
We usually release the draft report within 3 weeks of database lock.

For additional questions or to schedule a demo, please contact:

Jules Mitchel, President
212-681-2100
julesmitchel@targethealth.
http://blog.TargetHealth.com
www.targethealth.com