Agile Development Institute
On completion
An ADI micro-credential, with a link anyone can check
Length
Your own pace
Price
$399.00
ADI Certified Professional badge: AI in Life Sciences

AI in Life Sciences is the course a pharma, biotech or contract research organization can ask every associate to take once a year. It is not a tools course and it is not a lecture. Every lesson opens with the rule that protects the patient, the sponsor and the company, and then shows the productive use of AI that fits inside the rule — in whichever assistant your company has approved: Claude, ChatGPT, Gemini, Microsoft Copilot or an enterprise tool built on one of them. Six colleagues at a mid-size CRO carry the examples: Marisol, an executive assistant; Devon, a clinical research associate; Priya, a clinical data manager; Tomas, a biostatistician; Amara, a drug-safety associate; and Ken, a VP of clinical operations. You follow their decisions and then make your own. Level 1, Foundations, is the compliance core for every associate: how these tools really work and how they fail, the four house rules, patient data, sponsor and company data, records and data integrity, asking well and checking always, the everyday tasks that are safe, and ethics, bias and how to raise a concern. Level 2, Practitioner, is role work: a module each for administrative and operations roles, clinical operations and clinical data, and data science and technology, ending with a real, verified piece of your own work. Level 3, Leader, is for executives, managers and anyone who approves an AI use: the FDA, EMA and ICH positions on AI, the EU AI Act and privacy law, the standards and frameworks, how to govern AI inside a GxP organization — policy, inventory, risk tiers, vendors, contracts, incidents, monitoring — and how to lead adoption with a business case, a culture plan and an annual cycle. Four house rules run through every lesson: verify before you rely; protect what is not yours to share; disclose when AI helped; you stay accountable. Every regulatory statement names the document it comes from and carries the date it was checked. Each level ends with a quiz and a capstone you upload — scored against a published five-row rubric — and a credential with a number anyone can check on our public verification page.

What it covers

  1. 01Module 1 — How AI works, and how it fails
  2. 02Module 2 — Protecting what you must protect
  3. 03Module 3 — Working with AI safely day to day
  4. 04Module 4 — AI for administrative and operations roles
  5. 05Module 5 — AI in clinical operations and clinical data
  6. 06Module 6 — AI in data science and technology
  7. 07Module 7 — The regulatory landscape for AI
  8. 08Module 8 — Governing AI in a regulated organization
  9. 09Module 9 — Leading adoption

Who it is for

  • —Every associate of a pharma, biotech or CRO who will use an AI assistant at work — the Level 1 compliance core
  • —Administrative, operations, finance, HR, contracts and project-coordination staff
  • —Clinical research associates, clinical data managers, medical writers, drug-safety and pharmacovigilance staff, regulatory affairs
  • —Biostatisticians, statistical programmers, data scientists, epidemiologists, software and platform engineers, IT and information security
  • —Executives, people managers, quality assurance, compliance, privacy and legal — the people who approve AI use and answer to inspectors and sponsors

Before you start

  • —A role in, or supporting, a pharmaceutical, biotech or clinical research organization. No technical background
  • —Access to the AI assistant your company has approved (the course never asks you to sign up for a tool of your own)
  • —Your company's AI use policy, data classification and approved-tool list, if they exist — Lesson 3 shows you where to look
  • —About 45 minutes per lesson, plus the time to do the move on your own work

Claude is a trademark of Anthropic, PBC. ChatGPT is a trademark of OpenAI. Gemini is a trademark of Google LLC. Copilot is a trademark of Microsoft Corporation. This course is produced independently by the Agile Development Institute and is not affiliated with, endorsed by, sponsored by or certified by any of them, nor by any regulator. Nothing in this course is legal advice: your company's policies, SOPs and sponsor agreements govern, and your compliance, quality, privacy and legal functions have the final word. Regulatory statements are dated and reviewed quarterly.