Clinical-Grade AI Consulting
Evidence-based AI evaluation and implementation for life-sciences and healthcare organizations.
I’m Kedarinath Talisetty, CCDM® — a Senior Clinical Data Manager with 12+ years of oncology clinical research, 6.5 years at a top-tier global pharmaceutical company, and a decade of hands-on work with regulated clinical systems (EDC, CTMS, eTMF, pharmacovigilance). I help clinical research, healthcare, and pharma teams evaluate and deploy AI tools against clinical-grade evidence standards instead of marketing hype.
I offer three productized engagements. All are fixed-scope, fixed-fee, and delivered with the same rigor used to evaluate a clinical trial: a documented rubric, hands-on testing, and a written final report you can hand to your compliance, IT, or leadership stakeholders.
1. AI Readiness Audit — $2,500
Who it’s for
Clinical research organizations, CROs, and mid-size biotechs who have been asked “what should we be doing with AI?” and need a credible, vendor-neutral answer inside 2 weeks.
What’s included
- One 90-minute discovery interview with up to 3 stakeholders
- Review of 1–2 core workflows (e.g., query management, medical writing, PV case processing)
- Shortlist of 5–7 AI tools mapped to your workflows, scored against a clinical-grade rubric
- Written 15–20 page report with prioritized recommendations, pricing, regulatory and data-privacy flags
- 30-minute walkthrough call to present findings and answer questions
Turnaround: 2 weeks from kickoff call.
2. AI-for-Clinical-Research Workshop — $5,000
Who it’s for
Data management, biostatistics, medical writing, or pharmacovigilance teams (8–25 people) who want to go from “we’ve heard about AI” to “we know how to use it on Monday morning.”
What’s included
- Half-day (4-hour) live workshop, delivered remotely or on-site
- Role-specific modules: prompt engineering for CDMs, AI for SDTM mapping, AI for literature reviews, AI for safety case triage
- Hands-on exercises with ChatGPT, Claude, and one domain-specific AI tool of your choice
- A customized 20-prompt “playbook” PDF keyed to your team’s core tasks
- 60-minute follow-up office hours session 2 weeks after the workshop
Turnaround: 3 weeks from booking (includes pre-workshop team survey).
3. Fractional AI Advisor — $8,000–$12,000 / month
Who it’s for
Clinical-stage biotechs, CROs, and healthcare-SaaS companies who need senior AI guidance embedded in their team but don’t need a full-time hire yet.
What’s included
- 2 half-days / week of advisory capacity (8–10 hours weekly)
- Weekly working session with the leadership team or AI implementation squad
- Vendor evaluation, RFP review, and reference calls on your behalf
- Review of draft data-privacy, IT-security, and GxP documentation for AI deployments
- Async Slack / email support during India business hours (IST)
Minimum engagement: 3 months. Most clients stay 6–12 months.
Why this matters for regulated environments
Most AI consultancies come from a pure tech background. They’ll sell you tools. I come from a clinical data management background. I’ll ask you what ICH-GCP, 21 CFR Part 11, HIPAA, GDPR, and CDISC are going to say about the tool before you deploy it. That is the difference between an AI pilot that dies in validation and one that reaches production.
Book a 20-minute fit call
Calendly scheduler goes here.
Until the Calendly widget is wired up, please email [email protected] with your name, company, and 2–3 time windows (IST) that work for a 20-minute introductory call.
No pitch. Just a sharp conversation to decide whether one of the three engagements above is a fit — or whether you’d be better served by someone else.
Kedarinath Talisetty, CCDM® — IQVIA → PRA Health Sciences → 6.5 years at a leading global pharmaceutical company → currently Sr. Global Data Manager. M.Pharm (Pharmacology, University 10th Rank, RGUHS). Based in Hyderabad, India; work globally.