Functionality is only one of eight dimensions that matter

|Magnus Värendh
Functionality is only one of eight dimensions that matter

Blog · Module C02 · Selecting Enterprise Systems

Functionality is only one of eight dimensions that matter

A new free resource — and a look at why feature lists keep letting selections down.
The Problem

Too many enterprise system selections in clinical development are run on a feature list and a sales demo. Yet choosing an EDC, a safety system, an IRT or an eTMF commits your organisation to a platform, a provider and a way of working for years — and it is hard to reverse once trials are running on it.

A selection done well is a filtering process: you begin with the full field of options and narrow it down, stage by stage, to the one solution that genuinely works for you. The trap is filtering on the wrong things. A capable system you cannot actually run, or the least-bad option left standing at the end, is not a selection — it is a near miss with a contract attached.

The Framework — Eight Dimensions

A real solution is far more than what the system can do. It is the services around it, the quality and regulatory credibility of the vendor, the architecture and security, the company match, the product roadmap, the cost and conditions, and the vendor's long-term viability. We call these dimensions — and the goal of a selection is the right profile across all of them, not the highest score on any one.

  • Functional capabilities — can it do what the work requires, across the range of trials you will run?
  • Service availability & delivery — can you get the services to run it, at the scale and coverage you need?
  • Quality & regulatory compliance — quality system, validation and GxP credibility. Often a hard gate.
  • Technical architecture, security & fit — how it is built, how secure, how it fits your landscape.
  • Company & vendor match — size, culture and ways of working; can you collaborate effectively?
  • Product strategy & roadmap — is this product a strategic focus, with a credible direction?
  • Cost & contractual conditions — the full cost of ownership and the terms around it, including exit.
  • Vendor viability — financial stability and the odds the vendor is a healthy long-term partner.
The Rule That Does Not Bend

The dimensions stay separate. They are never merged, never rolled up into a single weighted number. A strong architecture cannot buy back a weak quality foundation; a low cost cannot offset a failed GxP gate. The only direction the structure moves is downward: break a dimension into sub-dimensions to sharpen the picture. Dimensions decompose; they never collapse.

The vendor matters as much as the system. You are entering a multi-year relationship, not just buying software.

That is why three of the eight dimensions sit on the vendor side of the line — company and vendor match, product strategy and roadmap, and vendor viability. At enterprise level the vendor is always a first-class concern, and must be weighed as thoroughly as the system itself.

The Stages — Options Narrow as Confidence Rises

The same profile is re-expressed at each stage of the selection — as filters for the market scan, open questions in the RFI, use-case scenarios in the RFP, and verification in qualification. Each stage closes on a documented read-out before you commit to the next.

  • Strategic foundation — why and whether: business, system-and-vendor and technology strategy, including own-or-source.
  • Solution profile — what you are looking for, across the dimensions, with macro criteria, gates and stakeholders.
  • Market scan & RFI — exclude with confidence; fail weak options fast.
  • RFP & proof of concept — show me how it works for us.
  • Qualification & selection — verify, decide, contract.
New Free Resource — and What Is Coming Next

We have just added a new free resource to our homepage: a four-page Framework at a Glance that summarises the TriTiCon Way of running an enterprise selection — the eight dimensions, the rule that they are never collapsed into a single weighted score, and the five stages that take you from strategy to a contracted solution.

It is a standalone companion to our upcoming Module C02 — Selecting Enterprise Systems in Clinical Development, launching soon in TriTiCon Knowledgeworld with five chapters, full manuscript and a hands-on selection Toolbox.

Download the resource at triticon.com/pages/resources.

Magnus Värendh

Health Economics & Clinical Data Specialist

TriTiCon delivers clinical data management training based on extensive hands-on experience from real clinical trials across sponsors, CROs, and life sciences organizations. The training is developed by industry professionals who work directly with clinical data, systems, documentation, and cross-functional trial teams.

30+
Years Experience
100+
Clinical and Health Economic Projects