By John Ryan, Chief Technology Officer, Maprium 

For much of my career, I’ve built technology for clinical research. And when I look at Managed Access today, I recognise something very familiar. 

Clinical trials are among the most operationally complex environments in healthcare. Patient interactions, protocol changes, supply movements, safety information and critical decisions have to be managed across multiple organisations, countries and regulatory frameworks. 

That complexity exists for good reason. Patients, regulators and sponsors need confidence that the right decisions are being made, that processes are being followed consistently and that the information behind those decisions can be trusted. 

But clinical research didn’t always have the technology infrastructure it has today. 

Twenty years ago, as trials became larger, more global and more operationally complex, the industry was still heavily dependent on Paper Case Forms (CRFs),  spreadsheets, email and disconnected systems. Eventually, that model simply couldn’t keep pace. 

Purpose-built technology emerged because the complexity demanded it. 

Looking at Managed Access today, I think we are approaching a remarkably similar moment. 

Managed Access Has Become Strategic 

Managed Access Programs have evolved significantly. 

What may once have involved a relatively small number of patients, countries and stakeholders can now require coordination between global and local Medical Affairs teams, program managers, pharmacovigilance, Quality, Regulatory Affairs, Market Access, logistics partners and external service providers.
All of this can take place across multiple jurisdictions, each with different regulatory requirements, processes and timelines.

And as programs grow, so does the expectation for governance and oversight. 

Organisations need to know not simply whether patients are receiving medicines, but whether requests are progressing appropriately, whether decisions are being made consistently, where delays are occurring and whether emerging risks require intervention. 

Yet much of this work is still coordinated through combinations of spreadsheets, email, documents and systems that were never designed around the end-to-end operation of Managed Access. 

I’ve seen this pattern before. 

What Managed Access Can Learn From Clinical Research 

It would be easy to describe the evolution of clinical research technology as a move from spreadsheets to software. 

The more important change was deeper than that. 

As clinical research became more complex, the industry increasingly needed systems of record and governed workflows around critical operations. 

Decisions needed context. Actions needed ownership. Processes needed to be reproducible. Information needed to be structured and trustworthy. Leadership needed to understand what was happening without reconstructing the story from spreadsheets, emails and status meetings. 

Over time, technology became part of the infrastructure connecting sponsors, investigators, CROs, laboratories, imaging providers and regulators. 

That created something extremely important: operational visibility. 

Organisations gained a clearer view of increasingly complex global operations, enabling problems to be identified earlier and processes to be managed more consistently. 

Over the past two decades, clinical research has developed increasingly mature technology ecosystems to support this kind of oversight. 

Managed Access is much earlier in that journey. 

Technology Doesn’t Solve Complexity - It Makes It Manageable 

One principle that has remained consistent throughout my career in healthcare technology is that technology should never replace expertise. It should amplify it. 

Medical Affairs teams don’t need another dashboard for the sake of having a dashboard. Program managers don’t need another spreadsheet. And leadership doesn’t need another report generated two weeks after the decisions it describes have already been made. 

What they need is shared operational visibility. 

With the right infrastructure, teams can gain a real-time understanding of: 

• Which programs and patient requests are progressing as expected. 

• Where bottlenecks are beginning to develop. 

• Which decisions are outstanding, and who owns them. 

• Whether governance processes are being followed consistently. 

• Where operational risks are emerging before they become larger compliance or patient-access issues. 

• How program performance and patient access can be improved over time 
  
  

These are not fundamentally technology questions. 

They are operational questions that technology should make much easier to answer. 

Clinical research has spent decades developing technology ecosystems capable of supporting this kind of oversight. Managed Access is only beginning that journey. 

Building Good Software Starts With Understanding the Work 

People sometimes assume that building healthcare technology is primarily an engineering challenge. 

In my experience, it is just as much an operational one. 

I started my career as a diagnostic radiographer, and that experience has stayed with me throughout my career in technology. Healthcare professionals don’t think in terms of software features. They think about patients, decisions, processes and accountability. 

That principle has remained remarkably consistent as technology has transformed clinical research over the past two decades. 

The best systems start by understanding how people actually work. 

Where is information being lost? 

Where do decisions become delayed? 

Where does ownership become unclear? 

Where are people maintaining parallel spreadsheets because the systems available to them don’t provide the visibility they need? 

Where does governance depend on a particular individual remembering that something needs to happen? 

Those are often the places where technology can have the greatest impact. 

The goal shouldn’t be to digitise an inefficient process. It should be to understand the operation well enough to create a better way of running it. 

The Opportunity Ahead for Managed Access 

Managed Access is becoming an increasingly important capability for pharmaceutical companies. 

It can enable patients with serious or life-threatening conditions to access medicines outside traditional commercial pathways, while also creating opportunities for organisations to generate real-world insights and better understand how programs operate across different healthcare environments. 

But as Managed Access becomes more important, the infrastructure supporting it also has to mature. 

Clinical research went through this transition years ago. 

Its evolution shows that success wasn’t simply about adopting more technology. It was about becoming better at structuring processes, connecting information, establishing clear accountability and creating visibility across increasingly complex operations. 

I believe Managed Access is now reaching the same point. 

The organisations investing today in operational visibility, governance and purpose-built infrastructure will be better positioned to scale tomorrow — not simply by running more programs, but by running better ones. 

Technology itself should never become the story. 

If it is designed properly, much of it should disappear into the background, allowing the people delivering Managed Access Programs to concentrate on what actually matters: expanding access to medicines while maintaining the confidence, governance and oversight that patients, regulators and sponsors rightly expect. 

About the author 
Dr John Ryan is Chief Technology Officer at Maprium.
A technology entrepreneur and former diagnostic radiographer with a PhD in Computer Science, he has spent more than 20 years building technology across healthcare, clinical research and life sciences.
He was previously CTO and co-founder of Longboat, which was acquired by Advarra, where he subsequently held senior technology leadership roles including Chief Scientist and SVP of Engineering.
At Maprium, he leads the company’s technology strategy and product engineering.