When To Outsource — And How To Pick The Perfect Clinical Trial Partners

A conversation with Alex Nikanorov, director of clinical affairs, EMED Technologies

It’s a unique position to be in. EMED Technologies is both a clinical research sponsor and a supplier of devices to clinical trials. But the ability to see from both sides — to be a sponsor and a vendor— has allowed them to develop a clinical research outsourcing strategy that’s rooted in a holistic experience.

Here, EMED Technologies Director of Clinical Affairs Alex Nikanorov shares the company’s approach to deciding which clinical research functions to outsource and finding vendor partners that align with a company’s organizational goals.

Clinical Leader: When developing an outsourcing strategy for one of EMED’s at-home infusion therapy device trials, which activities have you chosen to outsource, and why?

Alex Nikanorov: Our outsourcing strategy is designed to leverage specialized expertise and optimize resource allocation, particularly for our infusion therapy devices like the SCIg60 and the VersaPump Infusion Systems.​

We commonly outsource clinical monitoring and site management because partnering with experienced organizations ensures site adherence to protocols and regulatory requirements.​ We also outsource clinical data management and biostatistics. By engaging specialists in data handling and statistical analysis, we enhance the integrity and reliability of our study results.​ Finally, we outsource medical device safety. Experts in safety monitoring help us ensure compliance with safety regulations and effective management of adverse events.​

Outsourcing these functions allows our internal team to concentrate on the development of advanced patient-centered infusion technologies. This enhances our internal efficiency and also brings in-depth knowledge and external experience that contributes to the overall quality of our clinical studies.​

For small to midsize medical device companies like ours, outsourcing is often more cost-effective than building in-house capabilities for all aspects of clinical research. By strategically selecting which functions to outsource, we ensure that our clinical studies are conducted efficiently, comply with regulatory standards, and support the successful development and approval of our infusion therapy systems and devices.

How has EMED Technologies’ experience as a vendor to pharma in clinical trials helped shape its outsourcing strategy for its own clinical trials?

It’s significantly shaped our outsourcing strategy through the holistic understanding gained from experiencing both sides of clinical research processes.

Pharma’s experience underscores the importance of leveraging specialized external expertise to ensure regulatory compliance, data integrity, and operational excellence. While EMED's internal team focuses more effectively on innovation and advanced product development. Integrated collaboration leads to better alignment with project goals, greater innovation, and a stronger overall contribution to organizational objectives.

The decision to outsource involves risk. How do you identify potential risks and develop ways to mitigate them?

We systematically assess several key risk areas to identify and address potential challenges early in the outsourcing process, including:​

• Vendor reliability: We evaluate the stability and track record (such as through due diligence, audit reports, statements, databases, and professional networks) of potential partners to ensure consistent performance and alignment with our project goals.​
• Communication challenges: We recognize potential barriers such as time zone differences and language discrepancies, especially in international collaborations, and we assess communication protocols.​
• Data security and privacy concerns: Given the importance of safeguarding sensitive information, particularly with our online software technologies, we scrutinize vendors' data protection measures to prevent unauthorized access and breaches, compliance with HIPPA, ISO standards, secure IT infrastructure, and training.​
• Data quality issues: Ensuring the accuracy and integrity of collected data is paramount; thus, we assess vendors' data management practices to mitigate risks related to data quality, their adherence to GCP guidelines for data quality. Vague documentation, SOPs, outdated systems, poor transparency, or hesitance to provide information are red flags.
• Unanticipated hidden costs: We remain vigilant about unforeseen expenses during the outsourcing process, which could affect project budgets and resource allocation.​

To address these identified risks, we implement the following strategies:​

• Working with established partners: We engage with trusted organizations that have proven expertise, particularly in infusion devices and therapies, to ensure quality and reliability in outsourced activities.​
• Comprehensive due diligence: For new partners, we conduct thorough assessments of their capabilities, track records, and financial stability. Diversifying our outsourcing partners also helps mitigate dependency risks.​
• Monitoring data handling practices: We regularly review how clinical data is managed, ensuring compliance with industry-standard security protocols to protect data integrity and confidentiality through remote vendors’ portals and on-site audits
• Transparent pricing models: Working with vendors to develop clear pricing structures with clear and comprehensive cost breakdown, itemized service costs, fixed fees, and pass-through expenses helps us identify and address any unexpected costs, thereby preventing budget overruns and ensuring financial predictability.​ Lack of clarity, vaguely described administrative fees and overhead percentages may not be acceptable.

What are some of the characteristics you’re looking for in a vendor? 

Our vendor selection strategy is meticulously tailored to align with the unique requirements of each vendor category, ensuring the success of our clinical studies involving infusion therapy devices.​

• Therapeutic expertise: We prioritize CROs with proven experience in infusion-based therapies and devices, immunology, and immunodeficiency diseases.
• Operational excellence: A demonstrated ability to manage timelines and regulatory compliance effectively is crucial. We seek partners who function as strategic collaborators rather than mere service providers.​
• Technological capabilities: Robust data integration platforms and real-time analytics are essential for efficient data management and decision-making.​
• System compatibility: Vendors must seamlessly integrate with the existing EDC systems to ensure smooth data flow.​
• Data quality assurance: Established protocols for data validation, cleaning, and management are vital to maintain data integrity.​
• Scalability: The capacity to handle data from multicenter and multinational studies is important as our trials expand globally.​
• Security measures: Robust data protection and confidentiality protocols are nonnegotiable to safeguard sensitive information.​
• Specialized vendors: Specialty pharmacies play a critical role in facilitating patient recruitment across different geographical areas, providing technical expertise and addressing clinical quality. Engaging specialized vendors with the necessary technical capabilities and certifications is crucial for the accuracy and reliability of at-home specific infusion therapy study components.​

By carefully evaluating vendors based on these characteristics and best practices, we built a robust network of partners that contribute to the success of our clinical studies.

What are your best practices for building and maintaining strong vendor relationships?

​We begin by setting transparent expectations regarding responsibilities, deliverables, timelines, and quality standards. This clarity helps prevent misunderstandings and provides a framework for accountability.​

We also regularly monitor KPIs, (including recruitment and enrollment rates, data entry and adverse event reporting timelines), which allows us to track vendor performance and ensure alignment with project goals. This proactive approach enables the timely identification and resolution of potential issues.​

Maintaining open and frequent communication is also essential to address issues promptly and build trust. We utilize collaborative tools such as video conferencing and integrated platforms to facilitate real-time communication and ensure all stakeholders are aligned.​

Moving beyond transactional relationships, we involve vendors in strategic planning and decision-making processes. This approach encourages innovation and aligns vendor contributions with our organizational objectives.​

In addition, we schedule periodic meetings to review progress, discuss challenges, and provide constructive feedback. This practice reinforces accountability and fosters a culture of continuous improvement.​

How do you manage and resolve any performance-related issues?

The studies begin with comprehensive planning and sustained oversight. We select, partners who are not only technically proficient but also aligned with our organizational values and therapeutic priorities.

Once a study is initiated, we implement a proactive performance monitoring strategy. This involves leveraging integrated systems such as the CTMS, eTMF, and EDC to track critical performance indicators and maintain high standards of data integrity. Weekly operational check-ins with vendor teams further support transparent communication and allow for early identification of emerging risks. This level of vigilance helps significantly reduce the incidence of performance issues, often preventing them altogether.

Should challenges arise, we undertake a structured root cause analysis with the vendor, using tools such as fishbone diagrams and the “5 Whys” methodology to accurately diagnose the issue, provide visual clarity and map potential causes. Based on these findings, we co-develop a corrective and preventive action plan, clearly delineating responsibilities and timelines. We then closely monitor the implementation of these actions to ensure they are both timely and effective.

Finally, we conduct a comprehensive review of lessons learned, integrating the insights gained into our internal processes and future study planning. This continuous improvement loop strengthens our outsourcing framework and helps ensure consistent delivery of high-quality clinical research outcomes.

Are there any other complexities or challenges with clinical research outsourcing to note?

To ensure successful outcomes, we proactively address the following key challenges:​

• Increasing Complexity of Clinical Trials. Modern clinical trials have become more intricate due to innovative study designs, adaptive protocols, and the integration of new technologies. This complexity can strain resources and coordination efforts.
• Data Security and Privacy Concerns. With the rise of digital technologies and remote patient-reported outcome (PRO) trials, ensuring data security and privacy has become paramount. The use of electronic PROs involves collecting sensitive personal and medical information, raising concerns about privacy and security.
• Regulatory Compliance Across Regions. Conducting clinical trials across different countries adds complexity due to varying regulatory requirements. Ensuring compliance with local laws and guidelines is essential to avoid delays and legal issues. Outsourcing provides access to regulatory specialists with extensive knowledge of both regional and international requirements, aiding in navigating these complexities.
• Ethical Considerations in Global Trials. Global trials involving diverse populations raise ethical concerns, including informed consent and equitable treatment. Not all ethical principles have cross-cultural validity, and informed consent, for example, may not be the best model to bring to lower-income countries that don't have the necessary resources.

To address these challenges, our approach includes thorough vendor selection, robust project management, and continuous monitoring. By aligning our outsourcing efforts with organizational goals and ethical standards, we strive to ensure the success of our clinical research initiatives.

About The Expert:

Alex Nikanorov M.D., PhD is an expert executive in the biopharmaceutical, MedTech, and healthcare industries, and is currently the medical and clinical affairs director at EMED Technologies. He received his M.D., PhD in BioMedicine from RS Medical University in 1996 and went on to Yale and Harvard universities to receive an advanced education in executive healthcare management. His expertise lies in global medical affairs, medical device products, clinical research, as well as AI, medical image recognition technology, and diagnostic imaging. Alex has held many leadership roles throughout his career, including a medical director and global lead at Takeda, director of medical affairs at LamaMed Solutions, and director of medical and scientific affairs at Abbott Laboratories. He is seasoned in engagement with regulatory authorities (FDA/EMA), payer communication, patient advocacy, and medical education, and is a member of the FDA Critical Initiatives Path.