Пять признаков того, что клинические испытания требуют внешней поддержки

5 Signs Your Clinical Trial Needs Outside Help By Jason C. Bork, Founder and President, Pintail Solutions When the protocol changes, site activation takes longer than expected, recruitment slows, a key team member leaves, or vendors begin working toward different priorities, timelines, budgets, quality, and, ultimately, patients may be at risk. At that point, sponsors may find themselves asking an important question: Should the internal team continue pushing forward, or is it time to bring in outside support? The right partner does not replace internal leadership or add unnecessary layers but instead offers support to strengthen the existing team, clarify priorities, fill critical gaps, and improve execution. Here are five signs that your clinical trial may benefit from outside help. 1. Your Team Does Not Have The Required Competency Clinical trials require a wide range of specialized capabilities, and few organizations have deep expertise in every area. When the required expertise is unavailable internally, teams may lose valuable time trying to develop it or make do with what they have. Decisions are delayed, risks are overlooked, and avoidable mistakes become costly. These challenges can begin during protocol development and continue through site selection, recruitment and retention, and study closeout. An experienced outside partner can provide immediate access to leaders who have managed similar challenges. They can assess the situation, apply proven approaches, and help the internal team make informed decisions with greater confidence. I have seen an external review board composed of clinical trial site leaders cause a sponsor to stop and completely reevaluate its protocol. The protocol was not executable, and the study would never have finished as written and would have remained difficult to complete even after multiple amendments. Because it lacked deep experience in this area, the sponsor had not fully recognized the unacceptable burden on both the patients and the sites. Every site would likely have deprioritized recruitment for the study. Although the review delayed the trial’s start, it significantly improved the likelihood that the study could be completed successfully. Experienced partners can also optimize the operational model. I have personally seen a renewed focus on study start-up produce site activations that were up to 35% faster. New recruitment tactics, site and patient engagement methods, and retention strategies are available, but organizations must be willing to look for them. Whether a team is entering a new area or working in one where it already has substantial expertise, yesterday’s practices may no longer be today’s best practices. External experts can help identify better approaches. 2. Your Team Does Not Have Enough Capacity Most research and development organizations operate with lean teams. That model can work well until an acquisition, funding milestone, regulatory deadline, protocol amendment, new study, or unexpected operational challenge creates a sudden increase in workload. Sometimes an increase in capacity needs can be forecast. Other times, it comes as a surprise. Capacity constraints are especially common in clinical development. Experienced leaders may become consumed by urgent tasks, leaving less time for strategic oversight, risk management, and coordination across the study. The work may still get done, but execution becomes increasingly reactive. Decisions are made in isolation, follow-up becomes inconsistent, and important risks remain unresolved longer than they should. Outside support can add experienced capacity without requiring the sponsor to immediately hire full-time employees or build an entire function. Support may include a fractional clinical leader, project manager, clinical research associates, monitors, or specialists in study start-up, site feasibility, patient recruitment, monitoring, vendor oversight, quality management, regulatory strategy, data management, or study closeout. We worked with a rare disease company with several overlapping BLA submissions that taxed their internal staff. Pintail Solutions provided the capacity and expertise to deliver their BLA to an aggressive timeline. When the BLA was submitted ahead of schedule and the resource constraint was relieved, our engagement ended. While our personnel were no longer there, the company still uses the tools and best practices we left behind. The objective is not simply to add more people. It is to add the right experience in the areas where additional leadership and execution support will have the greatest impact. 3. The Trial Or Operating Model Requires A Different Perspective Sometimes a study or sponsor needs a different way of thinking. Internal teams can become constrained by established processes, organizational expectations, legacy decisions, or a narrow range of experience. This is especially common in larger organizations, where teams may be highly capable within their defined responsibilities but have limited flexibility to work outside familiar models. A trial may require a new site strategy, a different recruitment approach, an innovative partnership model, or a more effective way to coordinate academic, clinical, and industry stakeholders. When Eli Lilly and Company developed its Chorus model of external drug development, it recognized that the model would not be successful within Lilly’s existing organization. Planning and execution would have looked too much like the company’s established processes. Lilly intentionally created a separate organization with a unique reporting structure so that the team could think differently about drug development. The group rewrote its SOPs because it found that many of Lilly’s existing procedures were more conservative than the regulations required. Similarly, pre-screening studies can accelerate recruitment by bringing highly phenotyped participants to clinical trial sites. I’ve seen this approach reduce screen-failure rates and eased the burden on both study participants and sites. And while, sponsors believe they can execute a pre-screening initiative on their own, it’s difficult without investing significant time to determine how to execute it differently within their organization.Company culture and formal and informal processes drive behavior. Those behaviors are often consistent across an organization and can constrain new initiatives before they have a meaningful opportunity to succeed. An outside partner can deliver differently without being restricted by “how we have always done things.” The partner can then transfer that capability to the internal organization as needed. Outside partners also bring ideas from other organizations, therapeutic areas, and operating environments. Because they are not tied to existing assumptions or internal politics, they can ask different questions and identify options that may not have been considered. The value lies in the ability to evaluate the trial, function, or organization objectively and determine whether a different approach could improve speed, quality, or the likelihood of success. 4. The Study Needs Recovery Support A struggling clinical trial does not always need to be restarted. It often needs focused leadership, a realistic recovery plan, and stronger accountability. Warning signs on a study scorecard, and every study should have one, may include repeated missed milestones, delayed site activation, enrollment shortfalls, unresolved monitoring findings, inconsistent documentation, vendor performance issues, or limited visibility into study progress. Those are the issues that can be seen, but the underlying causes are often poor governance and oversight, unclear accountability, insufficient process discipline, or limited communication. These problems are often connected. A recruitment issue may be connected to site selection. A quality issue may reflect unclear responsibilities or insufficient oversight. A timeline delay may result from multiple dependencies that were never fully integrated. An outside leader can assess the study, identify the root causes of underperformance, and create a practical path forward. This may include resetting timelines, clarifying decision rights, prioritizing work, strengthening governance and accountability, resolving quality risks, or improving the team’s operating cadence. Recovery requires more than a revised project plan. It requires the discipline to identify root causes and the willingness to address difficult challenges. We once rescued a $100 million portfolio of COVID-19 clinical trials without amending the protocols, changing sites, or introducing substantially different recruitment tactics. First, we defined roles and responsibilities across multiple academic institutions, key stakeholders, partners, and trial sites. Then, we addressed conflict within the internal team with numerous one-on-one conversations to understand concerns, rebuild trust, and identify the sources of disagreement. Next, we reinstituted program governance, tracking, and follow-up across the portfolio. Finally, we centralized document storage and developed trial-level standard operating procedures and templates. These changes harmonized delivery across the trials and strengthened the sponsor’s ability to conduct future studies with less external leadership. Coming in late to salvage a stuck trial is extremely difficult. The goal should always be to intervene early enough to preserve options, protect the study, and restore confidence across the team as quickly as possible. 5. Your Team Needs Experienced Guidance Even strong clinical teams can benefit from an experienced advisor who has faced similar situations and understands what effective execution looks like. An outside advisor can help leaders determine whether plans are realistic, assess whether vendors are delivering as expected, and identify risks before they become larger problems. Advisors can also coach less-experienced team members, strengthen decision-making, and provide practical guidance without taking ownership away from the sponsor. Relationships also matter. Experienced clinical leaders often understand how to work effectively with investigators, sites, CROs, laboratories, technology providers, academic institutions, and other partners across the clinical ecosystem. In many cases, they already have established trusted working relationships with these organizations. The strongest outside partners combine experience with accountability. They are willing to challenge assumptions, communicate difficult information, and help the team apply lessons learned from other programs. Choosing The Right Outside Partner Recognizing the need for support is only the first step. Sponsors must also determine what type of partner will create the most value. A broad outsourcing model may be appropriate when an organization needs extensive operational infrastructure. In other situations, a focused consulting team or fractional leader may be all that is required. Clinical leaders should consider several questions: - Does the partner understand both strategy and execution? - Does the partner understand team dynamics, culture, and organizational change? - Does the partner have direct experience with similar trials or challenges? - Can the partner adapt its approach to the sponsor’s size, stage, and culture? - Will the partner provide recommendations from a distance, or will it embed within the organization and work as an integral part of the internal team? - Is the partner prepared to challenge assumptions and communicate candidly? - Will the partner build sustainable capabilities rather than create long-term dependency? The strongest relationships feel less like traditional outsourcing and more like embedded partnerships. Outside Help Should Strengthen Ownership By bringing in an outside partner, sponsors recognize that successful execution sometimes requires additional competency, capacity, perspective, recovery leadership, or experience. The right partner should help the internal team make better decisions, improve accountability, strengthen execution, and protect the study’s opportunity to deliver meaningful results. The best time to seek support is not after every available option has been exhausted. It is while experienced help can still create new options. About The Author: Jason C. Bork is a life sciences executive with more than 30 years of experience across large pharma, CRO, and startup organizations. He is an entrepreneur known for seeing the essence, distilling the complex into actionable steps, and developing those around him to new levels of fulfillment. From business strategy, organizational change, and operational excellence, Jason enables organizations to solve critical challenges, deliver high-impact projects, and move into the future with clarity and confidence. He has authored multiple scientific papers and book chapters and is a distinguished public speaker. Jason founded Pintail Solutions, a life sciences consulting organization, in 2015.