Why it matters
The everyday problems in clinical trial operations
If you run studies, you know these. Here is what the published data says, and how we help.
- 31.4 weeks
- from site identification to study start-up, about a month longer than a decade ago
- 76%
- of protocols in a 2022 industry sample had at least one amendment, averaging 3.3 each
- 260 days
- on average from identifying the need to amend to the last oversight approval
- ~$40,000
- direct cost per day of running a Phase II or Phase III trial
Sources: WCG, Decoding the Top Site Challenges of 2024: Study Start-Up (2024); Getz K, Smith Z, Botto E, et al. New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance. Ther Innov Regul Sci. 2024;58:539-548; Smith ZP, DiMasi JA, Getz KA. New Estimates on the Cost of a Delay Day in Drug Development. Ther Innov Regul Sci. 2024;58(5):855-862.
Problem and fix
Start-up takes months
Sites report an average of 31.4 weeks from site identification to study start-up. Source
How we help: Protocol AI drafts the plan from the protocol, so start-up tasks are ready on day one.
Protocols change often
In a 2022 industry sample, 76% of protocols had at least one amendment. Source
How we help: Your team updates the approved plan after an amendment, with the history kept.
Delays are expensive
Direct trial costs are estimated at about $40,000 per day for Phase II and III studies. Source
How we help: One shared plan with owners and due dates makes slipping tasks visible early.
Deviations lead to findings
Not following the investigational plan remains one of the most common FDA findings for clinical investigators. Source
How we help: Deviation logs sit next to the plan, so issues are recorded and followed up.
Tools do not connect
Plans live in spreadsheets, email and shared drives, so versions drift and decisions are hard to trace.
How we help: One plan, one history of who changed what and why.
Figures are published industry estimates, not Manakiki results.
See your own protocol turned into a plan
Bring a protocol, or use our sample study. In 30 minutes you will see the extracted schedule, the generated plan and what your team reviews before anything goes live.