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  • Boris Reznik, PhD | Nilufer Celenk

    Project Management Best Practices How to Use Proven Methodologies to Develop Successful Clinical Research Programs

  • How to Use Proven Methodologies to Develop Successful Clinical Research Programs

    Clinical trials share many similarities with complex projects in other industries: they have a defined objective, extensive budgets and timelines, a team spread across multiple departments and locations, and strict industry standards and regulations to follow.

    As clinical trials become more complex and costly, the need for skilled project managers to oversee them is more important than ever. Project management methodologies drive success for enterprise organizations in all sectors. These same principles can help pharmaceutical and biotech companies run more efficient, successful clinical trials.

    Some pharmaceutical companies and CROs promote Project Managers from within. However, a research scientist or monitor most likely won't have experience in project management techniques. Those techniques, along with a scientific or medical background and soft skills, are what's needed today to keep complex clinical trials on time, on budget and within quality, regulatory, and resource constraints.

    Why You Need a Professional Project Manager on Your Team Clinical trials contain a dizzying amount of moving parts: study startup, patient recruitment, screening and enrollment, multiple research sites, labs, product, data, materials, and people. In many cases, a clinical trial will have functional managers to oversee those moving parts. Even so, the project manager oversees those functional managers and takes responsibility for any mistakes they make.

    Think of the project manager as your clinical trial's CEO. They guide a large team to success while staying mindful of the big picture. They also provide the following beneficial services:

    Keep Studies on Schedule Timelines—specifically, meeting them—concern most clinical trial sponsors. For every day a study falls behind, a sponsor potentially loses millions due to delayed product launch.

    Our research indicates about 33% of all clinical trials are behind timelines at any given moment. This is consistent with a study led by Harold Glass, PhD, a research professor

    at University of the Sciences in Philadelphia, which analyzed Phase III studies reported on The study's conservative estimate showed about 33% of studies did not complete within one month of their originally estimated completion date.1

    A qualified project manager understands the industry and study protocol well enough to set a realistic schedule. They can look at the study protocol at a high level and determine what the team can achieve within a specific time frame without compromising quality. With realistic timelines set from the get-go, studies run more smoothly with fewer costly complications.

    Prevent Issue Escalation Minor issues can easily snowball into major problems if they're not reported and resolved quickly. This drives up costs and causes unnecessary delays.

    Experienced project managers plan for potential barriers that could hinder a trial's success. For each obstacle, a project manager develops a strategy to control that obstacle and monitor improvement.

    Possible obstacles include resource issues, rogue sites, contractual issues, unmet enrollment targets, and any number of small fires. Planning for "what ifs" in the form of a comprehensive risk mitigation plan keeps a study on schedule.

    Ensure Transparency and Communication Professional project managers have a master project plan. They regularly review and share status updates with their team and stakeholders informing them of that plan's progress, critical path items and any barriers/dependencies.

    Without this level of transparency and communication, errors crop up, tasks don't get done and unnecessary delays ensue. However, when functional managers and other project team members understand the overall goal and its progress, they're more likely to work together to sail the ship in the right direction.

  • How to Use Proven Methodologies to Develop Successful Clinical Research Programs

    3 Things to Look for in a Project Manager A clinical trial project manager needs to understand the science of project management first and foremost. A combination of innate and learned skills helps them manage project deliverables, patient recruitment, site management and regulatory demands. The most successful project managers have a combination of the following three qualities:

    1. Professional Project Management Experience If your company runs complex, large-scale clinical trials, you want a project manager at the helm with a background in Project Management Institute's project management methodology. They may have a Project Management Professional (PMP) certification, an MBA or systems engineering experience. Whatever their history, look for a combination of project management book smarts and practical experience.

    2. Soft Skills A person can learn how to use software or follow a system. Certain qualities, called "soft skills" in the corporate world, come from within. Whether the following three soft skills can be taught is debatable. We do know they can be improved upon.

    • Communication The project manager regularly communicates with people involved in clinical, data, safety, regulatory, quality, and oversight aspects of a clinical trial. They also regularly present information to internal stakeholders and sponsors. Naturally, good project managers know how to communicate clearly both orally and in writing.

    Strong communicators have the ability to collaborate with individuals at all levels. They outline communication guidelines for staff as well as communicate goals and expectations.

    Project managers know to update stakeholders when a study falls behind on enrollment. They actively listen to information given by investigators, sponsor representatives, upper management and staff. They also accept feedback and criticism with professionalism. They must do all this while navigating internal political and cultural differences, as well as an ego or two, with grace.

    • Leadership Outlining roles and responsibilities for everyone on the team is only the beginning of a project manager's leadership role. They hold the desired outcome in mind (the vision) and guide the team toward that vision. They keep sight of that vision while staying on top of thousands of small tasks.

    Project management leaders maintain high ethical standards, professionalism and a positive attitude, which builds trust within the team. They lead that team to a successful outcome without micromanaging. Instead, they leverage each person's strengths to help them succeed.

    • Problem Solving Not everyone can think on their feet and make smart decisions in a crisis. This is a definite strength for a role that involves managing hundreds of moving parts over a long period of time.

    Project managers with good problem-solving skills develop resourceful approaches for smoothing the many bumps in the road that take place over the course of a clinical trial. In clinical research, this includes knowing who to ask to help resolve a problem efficiently and effectively. A good problem solver can look at an issue from many angles, objectively, and develop steps to its solution.

    3. Clinical Research Understanding The ideal clinical trial project manager will have a combination of professional project management, soft skills, and an understanding of the clinical trial process. They may have a science or medical background or experience working at a pharmaceutical or biotech company or regulatory agency. It's not easy to find individuals with all three traits. When you do, you've found what Nilufer Celenk, Biorasi's vice president of project management, calls your "unicorn." "We're a unique breed," she says. "We understand our clients, the industry, the process and the people."

  • How to Use Proven Methodologies to Develop Successful Clinical Research Programs

    Project Management Best Practices According to Project Management Institute, project management involves five key principles:

    Initiating – Outlining your project and obtaining proper approvals to begin. Planning – Developing a detailed project management plan to reach your goals. Executing – Completing and overseeing the completion of tasks as outlined in your project management plan. Monitoring and Controlling – Reviewing and tracking the progress of the project and making adjustments as needed. Closing – Completing the project and obtaining approval from the appropriate stakeholders.

    Biorasi Chairman Boris Reznik, PhD, who has built companies across several industries, describes these principles as "managing a project environment where you ensure your team knows—and you know—what needs to be done, by whom, when and how."

    Let's look at the "what-who-when-how" philosophy as it applies to clinical trials.

    What During the course of a clinical trial, a sponsor has multiple objectives to accomplish: regulatory submissions, site selection, training, patient enrollment, data management and monitoring and safety and pharmacovigilance, to name a few. Under all those objectives lie thousands of tasks. Without structure, those tasks become unmanageable. Even the most elaborate Excel spreadsheet won't cut it.

    Work breakdown structure (WBS), a philosophy used in professional project management, helps organize those tasks i