Selecting Enterprise Systems in Clinical Development

This course is ideal for Clinical Data Managers, Clinical Trial Managers, Project Managers, Vendor and System Managers, IT and Quality Assurance professionals, and clinical operations or procurement staff who plan, run, or influence enterprise system selections in clinical development.

It is particularly relevant for professionals working in sponsor organisations or CROs who want a structured, repeatable approach to choosing systems their organisation will depend on for years.

Yes, a foundational understanding of clinical trials and clinical development is expected.

This is an intermediate module focused on the practical realities of selecting enterprise systems. Participants should already be familiar with clinical development processes and the surrounding trial and data workflows. No prior experience of system selection or procurement is required, but basic clinical research knowledge is necessary.

Estimated learning time is approximately 5–9 hours, depending on your pace and background.

Yes! Once enrolled, you can access all course materials at any time and progress at your own pace. There are no deadlines or live sessions required.

Yes! Upon completing the course content and passing the certification test, you'll receive a certificate of completion. Note: The certificate supports professional development but is not a license or regulatory credential.

Yes. System selection in clinical development sits inside a regulated, GxP environment, and the course treats quality and regulatory compliance as one of the core evaluation dimensions, verified in depth during qualification.

It translates those expectations into practical selection steps: qualifying a vendor's quality system, embedding findings and mitigations into the contract, and handing the documented risks over to oversight.

Most courses treat system selection either as a generic IT procurement exercise or as a checklist bolted onto a data management course.

This course treats selection as a discipline in its own right, a structured, multi-dimensional method that weighs the vendor as carefully as the system and is built specifically for the regulated realities of clinical development.

Rather than a generic buying process, this module gives you a repeatable framework, from strategy and solution profile to qualification and contracting, that you can apply to any real selection.

This course supports professionals aiming for or currently working in roles such as Clinical Data Manager, Clinical Trial Manager, Project Manager, Vendor or System Manager, IT lead, or Quality Assurance professional.

It strengthens competencies in structured evaluation, vendor qualification, total cost of ownership, and contracting, skills that are increasingly critical as organisations take more ownership of the systems their trials run on.

The structured framework provided in this module helps you move from participant to someone who can plan, run, and defend an enterprise system selection.

Both. Alongside the teaching, the module provides a practical toolbox: the model as a one-pager, the solution-profile and macro-criteria templates, the market-scan tracker, the RFI and RFP packs, the evaluation framework, the proof-of-concept plan, and the qualification and contract checklists. When a real selection lands on your desk, you start there.

Yes. The module walks through each stage in turn: running an RFI with an exclusion mindset, shifting the RFP from "explain your solution" to "show us how it works for us", and knowing when a proof of concept is warranted and how to run one, all evaluated against your solution profile.

Yes. The final chapter covers making the formal, documented selection and turning it into an enduring contract, making qualification findings and vendor promises binding, and securing data portability and an exit strategy while you still have leverage.

They are natural companions. Selection identifies the risks; oversight manages them. The qualification findings and mitigations produced in this module feed directly into the oversight plan taught in B03, so the two modules connect end to end.