Next-gen clinical development

The last two decades have seen exponential growth in clinical trials – and costs.

With ever-increasing challenges and rewards for bringing a successful innovation to market, your development process must be efficient, effective and fast. Here’s how we can help.

How fast are your clinical trials?

New types of medicines, including cell and gene therapy, personalized medicine and mRNA, and ground-breaking interventions are changing the field of medicine. But developing them creates new complexities – and costs.

Worldwide, the number of clinical trials has increased from a few thousand in the year 2000, to more than 350,000 in 2023. The vast majority of these will not yield new treatments. The associated costs are not sustainable, and come on top of new, additional challenges:

• Margin pressure: A narrowing window of exclusivity, combined with the rising cost of clinical development are squeezing margins like never before.​
• Patient “scarcity”: Increasing competition for patients and tightening access requirements make finding clinical trial participants difficult.
• Trial complexity: Personalized engagement, new end points and therapeutic platforms all add to the complexity that biopharma companies must manage – and manage flawlessly.

How can pharma leaders benefit from the explosion of potential in new treatments effectively, efficiently, and profitably? Next-gen clinical development streamlines your development process, helping you:

• Bring new types of medicines and interventions to market faster
• Benefit more patients
• Improve their care experience

Together, we’ll make your clinical trials faster, more effective and with higher probability to succeed in the market.

Access to patients and markets

Gaining access to the resources you need for successful clinical trials can be the difference between a drug that reaches the market and a drug that stays mired in development. Our approach to access comprises three parts:

Redesigning protocols – optimized protocol design lays the groundwork for everything that comes next. We use external and internal data, a human-centric approach and GenAI technology to help you improve medical benefits for patients while managing regulatory and operational constraints.

Portfolio study and management – Being able to manage your portfolio in relation to market conditions, commercial potential, R&D pipeline and costs is key to increasing the probability of success. We support you in simulating long-term clinical trial budgeting and improving and automating your end-to-end portfolio process.

Hybrid clinical trials – the ability to monitor patients in their homes opens the door to a new world of possibilities. More patients, more diverse patients, less drop-out. Whether primarily remote or hybrid, clinical trials can become safer and more affordable, while providing access to a game-changing diversity of patients.

The future belongs to the pharma companies that can intelligently and efficiently apply human-centric design for all stakeholders and access the participants, investigators, and trial sites they need.

Speed up your operations

Trials take as long as they take. But the right technologies and agile strategies provide numerous opportunities for efficiency. We look at two strategies in particular:

Leveraging clinical data and AI – The potential for AI to upend clinical data analysis is second to none, but also entails new risks. We help you get the most out of this new technology and lay the groundwork to stay in the lead.

Using data to optimize clinical processes – The right clinical tools provide immense savings in time and resources.

Patient identification and collaboration with high performing sites are key value areas where data and AI can help. We support you in:

• Identifying eligible patients using inclusion / exclusion criteria combined with NLP techniques to automate protocol analysis.
• Identifying new high performing sites and HCPs from publication, clinical trial and social media data.

Trial execution is another key value area. We help you proactively monitor trials through insights and simulation across all dimensions, including patient recruitment, planning, supply chain, quality, and more.

Once a trial is over and the database locked, speedy data preparation and analysis for submission is instrumental. We help you with:

• Automation of meta-data preparation
• Clinical report generation
• Biostatistics code generation using GenAI.

To scale these high value use cases, there is a need for robust data foundations. We support you with the design and setup (including data models and standards) and integration into your clinical application landscape. Beyond primary use of data, a robust data foundation brings value in multiple ways, including helping with protocol design, identifying additional indications, or even implementing synthetic trials.

In our work with pharma leaders, we’ve seen the value of skilled employees to organize and carry out clinical trials. We’ve also seen those same employees spending significant amounts of time on repetitive, tedious tasks. Our offer helps you simplify and speed up operations, so you can deploy your most valuable people where their skills matter most and become an even more effective organization.

Effective organization

Streamlining trial processes not only minimizes waste, it makes it possible to swiftly identify the safety and efficacy of potential drugs, reducing risk, driving progress and improving patient outcomes. To bolster efficiency in clinical trials, we support you with:

Process re-engineering and its impact on the clinical operating model. From strategy though execution and change management, we help you craft effective processes and organization. This includes:

• Optimizing & automating clinical processes and data flows
• Defining impacts on organization and tools
• Defining clinical operations target operating model
• Defining & executing change management strategy.

Agile compliance – by embedding Intelligent RCQ best practices into every stage, we help ensure compliance, safety and speed. To predict and improve approval success by regulatory bodies, compliance efficiency is achieved through:

• Intelligent authoring
• Data engineering
• Report creation.

By optimizing processes, upholding safety standards, and embracing life-cycle management, we contribute to a future where innovative treatments are discovered faster, and reach people in need sooner.

Leading the future of clinical trials

We’re entering a new age of drug development, an age defined by complexity. Unprecedented volumes of data. Changing regulatory codes. And with the low-hanging fruit long gone, the interventions we’re looking for are harder and harder to find. That’s half the story.

On the other hand, today’s solutions make it possible to not only manage complexity, but to turn data into a massive source of value. This involves technologies like AI, but just as critically it requires a bottom-up realignment of processes and procedures around your people.

Next-Gen Clinical Development is about transforming your trials to make them integrated, multi-modal, self-learning and simple. Contact us, and let’s talk about the future of clinical development.