Case studies | Medicover Integrated Clinical Services

How to Manage Precision Medicine and IVDR regulation in Clinical Trials — Expert Interview

Paweł Jacewicz — Mon, 16 Jun 2025 08:29:08 +0000

Executive summary

Precision medicine is transforming clinical trials by improving patient selection and increasing success rates. Medicover MICS Precision Medicine Director – Hari Radhakrishnan, PhD, explains how regulatory bodies now expect precision approaches, especially in oncology and rare diseases. He highlights the challenges of IVDR, which requires stronger clinical evidence and parallel drug/CDx regulatory strategies. Sponsors increasingly seek partners who offer end-to-end capabilities from biomarker discovery to commercial CDx launches. Hari outlines how MICS provides integrated precision medicine and central lab services, helping sponsors streamline logistics, ensure data quality, and reduce regulatory risks. He also points to future trends: multi-omics, AI-driven biomarker discovery, and adaptive trial designs.

1. Precision Medicine in Clinical Trials

PAWEŁ JACEWICZ: Could you start by explaining why precision medicine has become such a critical focus area in clinical trials today?

Hari Radhakrishnan, PhD: Precision medicine has fundamentally transformed how we approach drug development because we’ve moved beyond the one-size-fits-all model. Today, we understand that genetic variations, biomarkers, and molecular profiles determine how patients respond to treatments. Traditional clinical trials have historically had high failure rates¹, often because we treat patient populations as if they’re all the same. By identifying the right patients for the right treatments upfront, we’re seeing dramatically improved success rates and faster regulatory approvals.

From a regulatory standpoint, agencies like the FDA² and EMA³ are increasingly expecting precision medicine approaches, especially for oncology and rare diseases. They want to see that sponsors have identified the patient populations most likely to benefit before bringing drugs to market.

PJ: In what ways is the shift toward precision medicine changing the approach to clinical trial execution and collaboration with external service providers?

HR: The complexity has increased significantly due to the shift toward precision medicine. We’re no longer just managing traditional clinical endpoints – we’re coordinating genomic testing, biomarker analysis, companion diagnostics development, and often real-time patient stratification. This requires service providers who can handle both the clinical and commercial aspects of precision medicine.

Sponsors are looking for partners who understand the entire continuum – from early biomarker discovery through to commercial companion diagnostic approval. They need providers who can navigate complex regulatory pathways while maintaining the flexibility to adapt as science evolves during the trial.

2. Regulatory Landscape & Challenges

PJ: The IVDR regulation and companion diagnostics are adding complexity to clinical development. What are the main regulatory and operational hurdles you see our clients struggling with?

HR: IVDR has been a game-changer, particularly for companion diagnostics. The transition from the previous IVDD⁴ to IVDR means much more stringent requirements for clinical evidence, quality management systems, and post-market surveillance. Many sponsors underestimated the timeline and complexity involved.

The biggest hurdles I see are: First, the clinical evidence requirements are much more robust – sponsors need extensive analytical and clinical validation data. Second, the notified body capacity is limited, creating bottlenecks. Third, many sponsors lack internal expertise to navigate these requirements effectively.

The biggest hurdles I see are: First, the clinical evidence requirements are much more robust – sponsors need extensive analytical and clinical validation data.

Operationally, we’re seeing sponsors struggle with parallel regulatory pathways – they need to think about drug approval and companion diagnostic approval simultaneously, often across multiple jurisdictions with different requirements.

PJ: How are these regulatory requirements influencing sponsors’ outsourcing strategies, especially in terms of lab services and precision medicine support?

HR: Sponsors are increasingly looking for partners who can provide end-to-end regulatory support, not just testing services. They want providers who have established relationships with notified bodies, understand the IVDR pathway intimately, and can provide the clinical evidence packages required.

We’re seeing a shift toward strategic partnerships rather than transactional relationships. Sponsors want partners who can grow with them from early development through commercial launch, because switching providers mid-development creates significant regulatory and operational risks.

Medicover MICS laboratory in Berlin, Germany.

3. Medicover Integrated Clinical Services Precision Medicine Capabilities – From Clinical to Commercial

PJ: Can you walk us through Medicover Integrated Clinical Services’ precision medicine and biomarker offering, with a special focus on IVDR-compliant and CDx testing services?

HR: Our precision medicine platform is built around three core pillars: biomarker testing, companion diagnostics development, and regulatory support. We operate IVDR-compliant laboratories with the infrastructure to support both clinical trial testing and commercial companion diagnostic development. New clinical trials often need the development of in-house assays in an IVDR-compliant manner. MICS is uniquely positioned to support these needs because of its wide network of labs, knowledge and years of experience in assay development and validation, clinical trial project management and regulatory compliance.

We can handle everything from biomarker discovery and validation through to commercial Companion Diagnostics launch.

What sets us apart is our end-to-end capability – we can handle everything from biomarker discovery and validation through to commercial Companion Diagnostics launch. Our labs are equipped for next-generation sequencing, immunohistochemistry, and molecular diagnostics. We have established QMS systems that meet IVDR, GCP and GCLP requirements to support clinical trials.

PJ: What makes our approach unique in helping sponsors not only manage complex testing during trials but also plan and execute companion diagnostics commercialization?

HR: Our unique value proposition is continuity and integration. Most providers focus either on clinical trial testing or commercial diagnostics – we do both seamlessly. When we start working with a sponsor in Phase I, we’re already thinking about the commercial companion diagnostic strategy.

We provide regulatory strategy consulting from day one, helping sponsors understand the IVDR pathway and building clinical evidence packages that will support both drug approval and companion diagnostic approval.

PJ: Why is it important for sponsors to already think about CDx commercialization early in clinical trials, and how do we support them in that continuum?

HR: This is absolutely critical. Companion diagnostic development timelines often run parallel to drug development, and any delays in CDx approval can delay drug launch. The regulatory requirements for CDx approval require clinical evidence that’s best collected during pivotal trials.

If sponsors wait until late-stage development to think about commercialization, they often find themselves needing additional studies or facing regulatory hurdles that could have been avoided. We work with sponsors to develop integrated development plans that ensure both drug and diagnostic are ready for simultaneous approval.

4. Integration with Central Lab Services

PJ: How does our precision medicine offering connect to our global central lab services?

HR: Integration is seamless because we’ve designed our systems to work together from the ground up. Our central lab network handles routine safety and efficacy testing, while our precision medicine team manages specialized biomarker and genomic testing. All data flows through our integrated reporting system, providing sponsors with unified reporting and data management.

PJ: What is the value for our clients when they consolidate precision medicine, biomarker testing, and central lab services with one partner?

HR: The value is enormous – simplified vendor management, integrated data flows, consistent quality standards, and single-point accountability. From a practical standpoint, it eliminates the complexity of managing multiple lab relationships and potential data integration issues.

Financially, it’s often more cost-effective because we can optimize testing strategies across the entire program rather than having siloed approaches. We can also provide better forecasting and resource planning when we have visibility into the entire testing portfolio.

PJ: From your experience, how does this integrated approach help clinical teams simplify study logistics, data flow, and risk management?

HR: Clinical teams are juggling incredible complexity in today’s trials. Having one partner for all laboratory services dramatically simplifies logistics – one contact point, one billing relationship, one quality system to audit.

From a data perspective, integrated systems mean faster turnaround times, fewer reconciliation issues, and cleaner datasets for analysis. Risk management is also simplified because you have one partner accountable for the entire laboratory strategy rather than trying to coordinate risk across multiple vendors.

CE-IVD kits. NGS-based, multi-gene kits for scalable solutions delivered by Medicover Integrated Clinical Services.

5. The Future of Precision Medicine and CDx in Clinical Trials

PJ: Where do you see the field of precision medicine and companion diagnostics heading in the next few years?

HR: We’re entering an era of multi-omics approaches – combining genomics, proteomics, metabolomics, and other data types to create more sophisticated patient stratification strategies. Liquid biopsies are becoming more sophisticated and will likely replace some tissue-based testing.

Artificial intelligence and machine learning will play increasingly important roles in biomarker discovery and patient selection. We’re also seeing movement toward real-time, adaptive trial designs where biomarker data can influence trial conduct in real-time.

We’re also seeing movement toward real-time, adaptive trial designs where biomarker data can influence trial conduct in real-time.

Regulatory agencies are becoming more sophisticated in their expectations and requirements, but also more supportive of innovative approaches that demonstrate clear patient benefit.

PJ: How is MICS preparing to help clients stay ahead of these trends?

HR: We’re investing heavily in next-generation technologies such as advanced genomic platforms and AI-enabled analysis tools. We’re also expanding our bioinformatics capabilities to handle the increasing complexity of multi-omics data.

From a regulatory standpoint, we’re building deeper expertise in emerging guidance documents. We’re also developing partnerships with technology companies to ensure we can offer cutting-edge solutions to our clients.

6. Personal Insight

PJ: What excites you the most about the work you and your team are doing in precision medicine for clinical trials?

HR: What excites me most is that we’re directly contributing to getting better treatments to patients faster. Every biomarker we validate and every test we help bring to market represents patients who will get the right treatment at the right time.

The science is evolving so rapidly that we’re constantly learning and pushing boundaries. Working at the intersection of cutting-edge science and practical application – helping sponsors navigate complex challenges to bring life-changing therapies to market – is incredibly rewarding.

We’re also building something unique at MICS – a truly integrated platform that can support sponsors from discovery through commercialization. That’s rare in this industry, and I believe it will become increasingly valuable as precision medicine becomes the standard of care across therapeutic areas.

Hari Radhakrishnan, PhD

Hari Radhakrishnan, PhD, is the Head of Precision Medicine at Medicover Integrated Clinical Services, bringing over a decade of expertise in genetic testing and precision medicine. In this role, he leads strategic initiatives supporting pharmaceutical and biotech partners in companion diagnostics. He guides projects from biomarker discovery and assay development to regulatory alignment and commercialization.

About Medicover Integrated Clinical Services

Medicover Integrated Clinical Services (MICS) is a strategic business organisation with the overarching objective to support the development and commercialization of innovative therapies and medicines. MICS focuses on clinical applications and clients from pharmaceuticals, diagnostics, biopharma, biotech, medtech and contract research organisations (CROs). MICS’ activities are organised along discrete service lines: Central Lab Partner Services, Site Management Organisation, Precision Medicine and Companion Diagnostics.

MICS has been providing bespoke services to clients and their patients for over 20 years, making strategic use of Medicover assets, including laboratories with state-of-the-art diagnostic equipment, medical clinics and hospitals, as well as the vast expertise and enthusiasm of a global workforce.

Essential Guidelines for Choosing the Right Central Lab Partner: Insights for Clinical Research Teams

Paweł Jacewicz — Thu, 30 Jan 2025 13:04:00 +0000

Summary

In this article, we explore what makes a reliable central lab partner and why this choice is crucial for the success of clinical trials. From ensuring seamless logistics to maintaining regulatory compliance, the right partner plays a key role in study efficiency. To gain deeper insights, we spoke with Michał Dyśko, Director of Business Development at Medicover Integrated Clinical Services . He shares his expertise on selecting the best central lab partner, discusses the latest industry trends, and presents a real-world case study showcasing how effective lab collaboration can drive trial success.

Paweł Jacewicz: We hear a lot about the importance of central labs in clinical trials these days. From your perspective, why are they so essential in today’s environment?

Michał Dyśko: Central labs play a pivotal role, especially now that clinical trials are more global and complex than ever. When you think about multi-regional studies or precision medicine trials, there’s a need for consistent, high-quality data that can be processed quickly. The number of precision medicine trials, which require specialized diagnostics and biomarker analysis, is rising. In oncology, nearly 50% of all trials are now focused on precision treatments, which require extensive molecular and genetic testing capabilities that central labs can effectively support.

Central lab partners ensure uniformity across all sites, which is critical for accurate results. They also offer a centralized system that can streamline logistics, from sample collection to data reporting, ensuring everything is aligned with the study’s objectives. This efficiency helps trials stay on track and within budget, which is increasingly important as trial costs and timelines continue to rise. At Medicover, we’ve seen how having a robust lab partner can significantly impact trial timelines and data reliability, helping clients make informed decisions faster.

PJ: That makes sense. What do you think clinical teams should really be looking for when they’re selecting a central lab partner?

MD: First and foremost, the lab has to be a good fit for the trial’s scope and needs. You want to look at geographic reach—can the lab handle multi-site trials across different regions? Then, there’s the range of services they offer. Do they provide all the necessary tests, from routine safety labs to more advanced biomarker assays? Regulatory expertise is another critical factor, especially when trials are conducted across multiple countries with varying compliance standards.

Finally, the ability to provide real-time data access is essential for transparency and fast decision-making.

At Medicover Integrated Clinical Services, we’re not just offering a service; we work as a partner, deeply integrating with our clients’ processes to ensure their specific needs are met, whether that’s through customized logistics, specialized testing, or regulatory support.

A few years ago, one of our clients—a mid-sized biotech company—was conducting a global phase III trial for a novel cancer therapy. They had chosen several clinical sites across Europe and North America, but they struggled with inconsistencies in how samples were processed at each location. Data discrepancies began to emerge, causing significant delays. This is where our central lab services came in. By standardizing their procedures across all sites and managing sample logistics centrally, we not only rectified the inconsistencies but also improved the overall efficiency of the trial.

One of our central lab partner affiliates laboratories in Munich, Germany.

PJ: Your insights provide a roadmap for companies preparing to select a central lab partner. I imagine the right lab partner can have a big impact on the success of the trial. How does that play out in practice?

MD: Exactly. The right lab partner can have a huge impact on timelines, data quality, and overall trial success. For instance, fast and reliable processing of samples means fewer delays in reporting results, which is crucial when you’re working on tight timelines. Poor lab performance can lead to delays, which in turn can delay regulatory submissions or even impact the clinical outcomes. Each year, we are approached several times by clients dissatisfied with their current providers or central lab partner solutions, looking for a partner who can offer reliable timelines, higher data accuracy, and greater consistency across sites.

Central labs also help ensure data accuracy—if the data isn’t clean and consistent across all sites, it can lead to re-analysis, further complicating the process. We’ve had numerous cases at Medicover Integrated Clinical Services where our proactive management and ability to process complex tests quickly helped clients hit critical milestones ahead of schedule, allowing them to move on to the next phase of their trials faster. The bottom line is that a strong lab partner can be the difference between a trial running smoothly or facing major roadblocks.

PJ: What about the common challenges teams face with outsourcing lab services? Any advice on how they can be overcome?

MD: Outsourcing lab services can be tricky. One of the biggest challenges is communication—if there’s a disconnect between the clinical team and the lab, it can lead to delays or errors in data. Another issue is inconsistent data reporting or results processing, especially if the lab isn’t fully integrated into the trial’s workflow. Delays in sample shipment or processing can also be a problem, particularly in multi-regional trials. To overcome these challenges, it’s important to have a lab partner that is proactive and transparent, offering real-time updates and dedicated project management. This is why we prioritize effective communication and a structured project management approach.

By assigning dedicated teams to work closely with our clients, we proactively address potential issues before they escalate, ensuring smooth trial operations and reliable data quality. This collaborative approach supports seamless trial execution and dependable results, aligning with our commitment to overcoming the typical challenges of outsourced lab services.

Sample Management Department at a Central Laboratory of MICS in Poland.

PJ: Where do you see the industry heading, particularly in terms of central labs’ role in supporting clinical trials? What trends should clinical teams be aware of?

MD: We’re seeing a shift towards more decentralized and hybrid models in clinical trials, which is reshaping how labs provide support. There’s a growing demand for local solutions, with testing done closer to patients or even at-home options, which makes trials more patient-friendly. At the same time, hybrid models—combining central lab partner services with local labs—are becoming more common to balance efficiency with convenience. Testing complexity is also increasing, especially with the rise of precision medicine and the need for more advanced biomarkers.

Wearables and remote monitoring devices are adding another layer, allowing us to gather real-time data, often from biomarkers, directly from patients. This not only helps streamline trials but also enhances data collection and analysis, leading to more precise outcomes. I’m proud that we’ve developed a model at Medicover Integrated Clinical Services is well-positioned to support these trends, offering both centralized and local lab solutions while staying ahead with advanced diagnostics and integration of cutting-edge data collection technologies.

PJ: Lastly, what sets Medicover Integrated Clinical Services apart from other central labs out there?

MD: For us, it’s about being more than just a service provider. We act as a true extension of our clients’ teams, integrating deeply into their processes to offer personalized support that aligns with their unique trial requirements. What truly sets Medicover Integrated Clinical Services apart is our comprehensive central lab services, offering access to advanced and complex diagnostics.

We’re proud to be a leader in the region, with a vast network providing over 12,000 tests across hundreds of labs and nearly 1,000 blood drawing points. This scale, combined with our expertise, makes us an ideal partner, whether our clients need a standard central lab partner model, a hybrid approach, or even decentralized solutions. We have the infrastructure, flexibility, and regional expertise to meet the growing demands of today’s clinical trials, all while ensuring seamless service and reliable data, which are crucial for trial success.

PJ: Thank you for the talk! Wishing you many successful projects!

About Michał Dyśko, MBA

With over 20 years of experience in the clinical trials industry, primarily within CRO companies and central labs, Michał Dyśko is dedicated to helping Pharma, Biotech, and CRO clients accelerate their clinical development programs. As Director of Business Development at Medicover Integrated Clinical Services, Michał leverages deep industry knowledge and a client-focused approach to optimize lab services and ensure that trials progress smoothly, efficiently, and with high-quality data at every step. Contact Michal on LinkedIn.

About Medicover Integrated Clinical Services

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