Category: Insights

By Gregg Beloff, Co-Founder and Managing Director

Biotech risk management is not just about insurance—it’s a comprehensive, proactive strategy that safeguards your organization against financial, operational, and clinical setbacks. As Molly Hatchet once sang,“I’m travelin’ down the road and I’m flirtin’ with disaster.”

I doubt the legendary southern rock band Molly Hatchet had biotech in mind with this lyric, but nothing more aptly describes the journey in life sciences: hallmarked by risk at every turn. These complex and dynamic risks impact not just science and clinical development, but capitalization, business strategy, operations, and general performance.

There is no singular defined risk, and no singular definition of risk management. Be wary of off-the-shelf templates; companies must do the work to assess and plan accordingly for risks identified in their early stages and onward.  

Where to start? Your biotech risk management approach must fit your company’s unique research and development as well as your organizational structure and culture. Importantly, risk management is not just the procurement of insurance, which is one way to transfer risk. Some risks cannot be insured. Read on for a checklist of functional areas to consider and a summary of the risk management process.

Biotech Risk Management Checklist by Function

Every functional area has risk. Some obvious and perhaps non-obvious examples include the following. 

Finance –The high prevalence of fraud and email phishing is well documented. Do you have the right combination of crime and cyber insurance coupled with documented controls for wires, disbursements, and new or existing vendor banking changes to protect against financial fraud?

Clinical Research Organizations (CROs) have been known to make errors in billing and related accruals.  Do you have a process of contract review and reconciliation to ensure against overpayment and inaccurate financial reporting?

Human Resources – Resumes can be both enticing and deceiving. Do you have a hiring documentation process that includes both a comprehensive background check and reference check?

Personal information must be protected. How can you ensure that personnel files are secured and there is no risk of inadvertent HIPPA disclosure?

Clinical Development – While the obvious risks of safety and meeting clinical trial endpoints garner the most attention, do you have contingency plans in the event that a trial is stopped, postponed or delayed? During the CRO selection and contracting process did you review the agreement for key risk management issues including replacement timeframes, insurance and indemnity?

Corporate Communications – Pitch decks are a common form of communication in life sciences, but do you have an agency to review for misleading, overly optimistic or off-script statements? What policies do you have in place to ensure that only authorized individuals make public statements?

The Process of Biotech Risk Management

Risk management in life sciences is about creating systematic approaches to identify and address potential threats before they materialize as well as identifying potential opportunities. While insurance helps pay for losses after they occur, effective risk management focuses on prevention and mitigation – supporting the protection of key assets, operational resilience and enhanced stakeholder confidence. Every company should have a holistic understanding of risk and a corresponding risk mitigation strategy which, at a minimum, does the following.

• Identifies and helps the organization leverage opportunities, thus enhancing shareholder value
• Fits the culture of the organization; supplements current controls/capabilities and reduces rather than increases bureaucracy
• Encourages staff to take “informed risk,” not be constrained by risk
• Identifies how issues are conjoined across the organization

All risk management approaches begin with the identification of both real and potential risks (threats) that could affect your organization’s strategy and/or operations.

The takeaway? Biotech risk management is a must-use yet often misunderstood tool in the toolbox. Start with an assessment, discuss the findings with your board of directors and build a plan. Be transparent with your investors; show them that you’ve done the work to protect their interests.

Suddenly that Molly Hatchet tune sounds less ominous!

Time is Money: Three steps to getting your clinical trial back on track

Clinical trials are complex, and even with the most thorough planning, challenges can arise that threaten enrollment, timelines, and overall quality. If your clinical trial is progressing differently than expected, acting quickly and strategically is crucial. Below are some actionable steps to help you get your clinical trial back on track.

1. Conduct Study “Health Checks” and Assess the Need for Expert Support

It is essential to conduct a thorough “health check” when a trial is not meeting its goals. This is especially critical where delays and quality issues can significantly impact a drug’s development timeline, regulatory submission, and eventual market entry. Even minor setbacks can result in costly delays, potential safety concerns, and lost competitive advantage. Close partnerships between sponsors, CROs, and expert consultants can identify root causes—whether they stem from patient recruitment challenges, site management, or protocol adherence—and support the successful development of mitigation strategies.

2. Carefully Match Clients with Specialized Consultants

Not all consultants are a fit for every clinical trial. Strategically matching a study with consultants based on their capabilities, experience, and company culture is crucial for success. 

3. Mitigate Risks, Implement Thoughtful Strategies

Successful clinical trials rely on seamless collaboration, between internal teams and external partners like CROs and other vendors. By integrating into the study’s daily operations, consultants can bridge gaps between various stakeholders, ensuring that communication flows smoothly and that no detail is overlooked. This cohesive approach is vital for maintaining study momentum, especially when timelines are tight, or challenges arise.

Conclusion

Falling behind on clinical trial goals is stressful, but with the right partnerships and proactive measures, clinical trial sponsors can turn things around. By conducting thorough health checks, strategically bringing in specialized consultants, and working collaboratively, they can improve enrollment, timelines, and study quality—putting a clinical trial back on the road to success.

At Elite Biopharma Consulting, a Danforth Advisors company, we specialize in providing expert support tailored to the unique needs of each clinical trial. Our team brings extensive experience across Clinical Operations, Clinical Program Management, Clinical Trial Management, Regulatory Affairs, Monitoring, and Medical Writing, ensuring your study gets the attention it deserves. We work as an extension of your team, partnering with CROs and sponsors to mitigate risks and drive performance. Whether you need a quick course correction or comprehensive oversight, we’re here to help you meet your goals and ensure the success of your clinical program.

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By Réne Stephens, Managing Director, Clinical Business Operations

Deciding on the right Contract Research Organization (CRO) is critical to your clinical trial success. However, many biopharma sponsors start the selection process without first engaging an outsourcing specialist. Unlike larger biopharma companies with in-house teams managing the outsourcing process, smaller organizations typically go without this specialized role. This can lead to a host of pitfalls and long-term consequences that may jeopardize your study.

• Incorrect fit. Like an outfit bought in haste, without an expert outsourcing “tailor,” executives or clinical teams may take the easy route by opting for a well-known, large CRO or one that has been recommended by a colleague or friend. While this seems like the path of least resistance, it may not always result in the best fit for the specific needs of the trial. Without proper analysis, you risk selecting a CRO that is too large or too small, or one that lacks critical capabilities your trial requires.

• Knowledge of CRO Landscape. Outsourcing specialists have their finger on the pulse of the CRO market. Without their involvement, executives may simply not know the full range of options. The CRO industry is vast, and new, innovative providers frequently emerge that may offer better capabilities, specialized expertise, or more cost-effective solutions. Without a specialist, sponsors often end up with suboptimal choices, missing out on better suited options.

• Clinical Operations Teams Have Different Priorities. Clinical operations teams rightly focus on study execution more than strategic alignment of outsourcing needs. They may not have the same objectives when it comes to due diligence and contract negotiations as someone in a procurement or outsourcing role. Clinical operations teams might prioritize operational efficiency and technical compatibility but overlook critical elements such as pricing structure, risk-sharing models, and quality guarantees. This could lead to a bad deal where the sponsor ends up overpaying or agrees to unfavorable contract terms, creating financial and operational strain down the line.

• Due Diligence Gaps. CRO selection is a complex process that goes beyond assessing basic capabilities. Without the rigorous vetting process that an outsourcing specialist provides, due diligence may be insufficient. Experts in the field guide teams through the process, ensuring a more robust and thorough analysis and freeing clinical operations teams so their focus remains on core delivery capabilities.  These areas of diligence are more than just box-checking exercises as they provide the underlying rationale to support selection decisions when compliance, regulators, and/or auditors come calling.

• Poor Negotiation Outcomes. Negotiating with a CRO without the guidance of an outsourcing expert often results in missed opportunities to optimize the contract. Outsourcing specialists have experience in understanding industry standards, negotiating flexible terms, and securing competitive pricing. Without their expertise, sponsors may lock themselves into contracts with rigid timelines, lack of milestones, or high financial penalties, ultimately reducing the sponsor’s leverage in managing the trial effectively.

• Conflicts of Interest: A common but often overlooked issue is when a CEO, executive, or key decision-maker favors working with a specific CRO due to personal connections—such as a recommendation from a colleague or a previous working relationship. While these relationships may seem beneficial initially, they can lead to a bias in the decision-making process, where the CRO’s past reputation or personal relationship takes precedence over actual suitability for the current trial.

How an Outsourcing Specialist Can Help

Outsourcing specialists bring an objective, data-driven approach to CRO selection. They know how to evaluate CROs based on key indicators like performance metrics, therapeutic area expertise, geographic reach, regulatory success, and financial stability. Their primary role is to ensure that the CRO selected is the best possible match for the specific needs of your trial, not just the most convenient or familiar option.

• Broader Market Knowledge: Outsourcing specialists have a comprehensive view of the CRO market, ensuring that all potential providers are evaluated, from large global CROs to niche, specialized players.

• Stronger Contracts: They bring the experience necessary to negotiate contracts that protect the sponsor, with favorable terms, performance guarantees, and clear, measurable milestones.

• Aligned Interests: An outsourcing specialist ensures that the goals of the sponsor—whether speed to market, cost control, or quality—are the priority during the entire CRO selection and contracting process.

• Risk Mitigation: With their focus on due diligence, they reduce the risk of selecting a CRO with inadequate capabilities or poor track records.

The takeaway? Engaging an outsourcing specialist before selecting your CRO is not an added expense—it’s an investment in the success of your clinical trial. The pitfalls of not doing so are many: from selecting a misaligned CRO, to signing unfavorable contracts, to experiencing costly delays. Ultimately, an outsourcing specialist acts as a vital guide through the complex landscape of CRO selection, ensuring the trial runs smoothly and efficiently, and reducing the risk of costly errors.

In today’s competitive clinical trial landscape, where every decision can impact time-to-market, quality of data, and financial stability, engaging an outsourcing specialist is essential to achieving your goals. 

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In the highly regulated and complex world of pharmaceutical research, clinical trial monitoring is a critical component that directly influences the success of a study. Ensuring high-quality data is not just about adhering to compliance standards; it is also about achieving accurate, reliable results that can make or break a drug’s journey to market. One key differentiator in the quality of clinical trial data is the level of experience of the monitors reviewing it. Experienced clinical trial monitors give the sponsors a higher touch of eyes and ears on-site to enhance and ensure the quality of the data.

The Importance of Experienced Monitors in Clinical Trials

Having the right monitoring expertise on your clinical study helps ensure the bottom line: good quality study execution, accurate and comprehensive data, and achievement of key milestones. Experienced monitors bring a wealth of knowledge and a critical eye, which are essential in identifying and resolving issues before they escalate. Their proficiency ensures that data anomalies are spotted early, protocol deviations are minimized, and regulatory compliance is maintained throughout the study.

The Value of Risk-Based Monitoring

Risk-based monitoring (RBM) with targeted on-site visits is a well-accepted and increasingly utilized approach to intensive on-site monitoring. This method focuses on the areas of highest risk to data integrity and patient safety, allowing for more efficient use of resources while maintaining robust oversight. However, the success of RBM heavily relies on the skill and experience of the monitors. Seasoned professionals can effectively implement RBM strategies, making informed decisions on where to allocate resources and when to intervene.

The Difference Between Clinical Trial Success and Failure

In clinical trials, the difference between success and failure often lies in the details. The level of experience of the monitors reviewing your data is a key differentiator in achieving high-quality outcomes. By leveraging the expertise of seasoned professionals, pharmaceutical companies can ensure that their studies are executed with precision, data is accurate and representative, and key milestones are met.

Finding the Right Clinical Operations Partner for Monitoring

At Elite Biopharma Consulting (Elite), a Danforth Advisors Company, we understand the critical role that experienced monitors play in clinical trial success. Our Clinical Operations consultants have decades of experience monitoring and managing studies across various therapeutic areas. This depth of knowledge, gained from working in both large and small biotech companies, equips our clinical monitoring team with the expertise to provide the best data quality oversight for your studies.

Customized Support Solutions for Optimal Data Quality

Elite provides clients with the unique opportunity to select the right consultant tailored to their specific needs. Clients have access to detailed bios and can engage in direct conversations to ensure a strategic fit between the consultant and the study requirements. Whether you need part-time to full-time support Elite offers flexible solutions designed to help your team maintain robust data quality and achieve critical milestone timelines.

By partnering with us, clients can eliminate the need for, or maximize the performance of, costly Contract Research Organizations (CROs). This approach not only keeps trials on time and within budget but also enhances data integrity and reliability, ultimately contributing to successful study outcomes.

Talk to us about the oversight you need to navigate the complexities of clinical trials, ensuring your research is on the path to success. Click here.