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Boris Reznik, PhD | Nilufer Celenk

Project Management Best PracticesHow 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 TeamClinical 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 ClinicalTrials.gov. 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 EscalationMinor 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 CommunicationProfessional 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.


3 Things to Look for in a Project ManagerA 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.

• LeadershipOutlining 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 SolvingNot 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."


Project Management Best PracticesAccording 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 into manageable sections. WBS is hierarchical and incremental. It divides projects into phases, deliverables and work packages. Visually, WBS uses a tree structure to show the steps involved to complete a project.

Originally used by the U.S. Department of Defense, NASA, and the U.S. Navy, businesses in all industries follow a WBS standard. Because WBS spells out every task and dictates the vision from the beginning, using it helps improve communication, prevent bottlenecks, and ultimately keeps the project on schedule.

WhoIf you imagine the project hierarchy as a pyramid, the project manager sits at the top. From there, the study team fans out to several departments, specialists, vendors and their staff.

The project manager outlines individual responsibilities for each team member. This not only helps the project manager get a sense of the smaller tasks that need to be accomplished, and by whom, but it also keeps the team focused. Everyone knows their role and the roles of others.

WhenSponsors worry about timelines more than any other aspect of a clinical trial—because falling behind costs money. Falling behind is the beginning of the path to failure.

Timelines are also one of the most challenging aspects of clinical trial project management. Within the larger timeline, defining milestones helps divide a complex clinical trial into smaller, more manageable phases. Considering clinical trials often stretch for two to 10 years, it's important to have sub-goals along the way.

When a clinical trial falls behind, even if it's due to a change in protocol, Reznik says it's ultimately the project manager's responsibility to adjust the plan to get it back on track.


HowThe "how" encompasses the many processes and procedures involved in running a safe, compliant clinical trial. The "how" includes writing and adhering to study plans, SOPs and operating in accordance with the ICH Good Clinical Practice guidelines.

It takes thousands of tasks—all outlined in the WBS—to accomplish the "what" with the right "how."

Why Clinical Trials Demand a Project Management-Centered ApproachToday's complex clinical trials require structured, methodical project management on par with any large-scale IT, engineering or construction project. Many CROs promote their best monitors into project manager roles. Reznik says that's not the best approach. "In most cases, they lose an extremely good monitor and don't gain a good project manager," he says.

Strong project management can yield big benefits for pharmaceutical and biotech companies. Indeed, the purpose of defined project management is to execute a project in a way that increases value to the client or customer. In project management philosophy, if a project does not deliver value—whether tangible or intangible—it should not be pursued.2

Stakeholders benefit from a project management approach in multiple ways. They receive a higher level of quality planning and quality assurance. A more structured project plan leads to improved control of budget and costs. Risk assessments help identify "red flags" early, which keeps a program running on time and according to budget. The contingency plans an experienced project manager puts in place helps them swiftly resolve these red flag issues.

While only select CROs use project management methodology, we can look to other industries for insight.

Tech giant Intel saw a huge productivity boost when it overhauled its IT department to adopt more rigorous project management practices. Two years into the new approach, 90 percent of the department's projects hit their release dates or went over by only a few days. The department also increased its total volume of projects from 402 in 2007 to 454 in 2009.3 Even a slight increase in product launches could mean huge profits for a drug company.

Biorasi carefully selects project managers that possess the trifecta of in-demand requirements: project management experience, clinical research knowledge and soft skills. These project managers are the hub of the clinical trial wheel. A study may have different groups to oversee different divisions, but the project manager has control over and visibility into all of them. When sponsors have questions about their study, the project manager can give them a quick answer.

TALOS™, Biorasi's proprietary data platform, houses the master Work Breakdown Structure that helps project managers create their own study-specific Project Management Plan. TALOS allows project managers to plan and execute successful strategies custom to each sponsor. Access to existing data and past studies allows them to derive insights to continually improve processes, systems and standards.

Biorasi is a technology-enabled, methodology-based, optimization-focused company. With professional project managers on staff, we consistently keep our sponsors' studies on time and on budget with an optimal outcome. Get in touch to find out how we can manage your program to a successful outcome.


1. Glass, Harold. "Are Phase III Clinical Trials Really Consistently Behind Schedule?" Applied Clinical Trials, June 30, 2016.

2. Phillipy, M. A. (2014). Delivering business value: The most important aspect of project management. Paper presented at PMI® Global Congress 2014—North America, Phoenix, AZ. Newtown Square, PA: Project Management Institute.

3. Project Management Institute. "The Value of Project Management." White Paper. 2010.

Resources

About the Authors

Boris Reznik, PhD, is a veteran of multiple startups and is backed by a track record of building companies

across a diverse set of industries. Dr. Reznik leads Biorasi with a strong focus on processes and systems—a unique

perspective in the CRO world.

Nilufer Celenk has over 17 years of operations and project management

experience. Her responsibilities include building out Biorasi's project

management team, as well as leading sponsor projects. She holds an MBA

from Loyola University and a B.S. from Istanbul Technical University.

Boris Reznik, PhDChairman

Nilufer CelenkVP, Project Management

19495 Biscayne Blvd. Suite 900 | Miami, Florida 33180786.388.0700 | www.biorasi.com

Biorasi, founded in 2002, has received the coveted CRO Leadership Award from Life Science Leader magazine and has placed on the Inc. 500 list of America’s fastest growing companies. Biorasi has collaborated with sponsors to enable FDA, EMA, and multi-venue approvals for numerous small molecules and biologics. Biorasi, headquartered in Miami, Florida,

maintains office-based teams around the globe.