Here’s what we’re proud of from the past 12 months:
1) Projects delivered:
– Received 34 requests for proposals
– Launched/prolongated 11 FSP engagements (3 DM/ 3 Stats/ 5 SAS Programming)
– Completed or advanced 7 project-based studies
– Performed 2 “rescue” engagements ahead of (or in parallel with) audits. 🦸♂️
Data Management highlights from one of our studies:
– EDC-to-Argus Safety integration, under pressure.
We were brought in late to rescue a complex setup for integrating AE data from the EDC into the Argus Safety pharmacovigilance database for regulatory reporting. The stream was overdue and the original dev team struggled. Our lead data managers re-architected mappings and checks, aligned schedules with safety, and stood up the pipeline fast.
Result: launch with < 3 weeks slip vs the original plan – audit-ready and stable.
– CCG that saves everyone time.
We finalized a CRF Completion Guideline (CCG) so clear and practical (examples, screenshots, FAQs) that with 40+ active sites we now see ~10 emails/week in total and only ~3/week are about CRF completion. Fewer site questions, cleaner data earlier, less rework for everyone.
2) Quality and compliance.
– Added a one‑year quality guarantee to all proposals: in the rare event a defect is found in our deliverables within 12 months of delivery, we fix it promptly at no additional cost. 🛡
– Our SAS programmers achieved an 85.7% first-pass validation rate on SDTM/ADaM packages
– Successfully passed 3 independent audits and kept improving our processes, SOPs, instructions, templates and LMS – aiming to raise the bar for quality in our space.
3) Innovation
– Built and continuously evolved our SAS code library with 34 new reusable automations/macros (13 for figures) — reviewed and hardened after every study so today’s lessons ship as tomorrow’s defaults. 🧠
– Started 3 internal initiatives:
a) TFL shell generator for Biostatisticians;
b) Test-dataset generator from the Architect Loader Draft Spreadsheet (Oracle Medidata Rave), with plans to incorporate AI;
c) Estimand Framework guidance and analysis of published protocols/SAPs to standardize estimand language.
4) Community and growth
– Ran 5+ team-building events and corporate activities.
We celebrated on SUPs – a reminder that great results come from balance, coordination, and trust.
Thank you to everyone who stands on the board with us.
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Happy 4th anniversary, TUNECT CRO!
