Realistic, well-managed clinical trial timelines are essential to the success and timeliness of clinical studies. Read on for more information about keeping your projects on track.
We often say every clinical trial is made up of a million moving parts. The materials, equipment, and supplies that support clinical trials must be accurate, engaging, and ready for use the moment they are needed. A trial’s success depends on having a multitude of deliverables ready at the right time and in the right places. Many questions must be addressed, including:
- Are recruitment materials getting to the appropriate targets in enough time to enroll patients?
- Are referring physicians receiving the trial information they need in a timely manner?
- Are visit guides ready when patients come to their screening visit?
- Do site coordinators have all the tools they need to manage patient procedures and scheduling?
The sheer volume of materials needed for clinical trials is massive. They range from simple appointment reminders to complex patient and professional materials to specific ancillary equipment and supplies.
Timelines: The Backbones of Success
A solid clinical trial timeline is the foundation for successfully developing and delivering all the materials mentioned above and more—from initial concepts and first drafts to approvals by Institutional Review Boards (IRBs) and Ethics Committees (ECs) and, ultimately, to on-site distribution and use.
Simply put, a timeline is a schedule of activities for an entire project from beginning to end. It breaks the project down into smaller tasks and milestones, with a deadline assigned to each. Every member of the project team must understand and agree on exactly when a task is due and delivery deadlines. The project manager is the conductor in charge of directing this complex production. The one who orchestrates every detail of the timeline to ensure the study stays on track.
Setting Targets Starts with the End in Mind
When developing realistic clinical trial timelines, the first step is to determine the dates each item must be ready to go. Working with that target date, the project manager then identifies all activities needed to meet that date along with the amount of time required for each one. A few examples of individual activities include:
- Discussing initial concepts
- Designing graphics and logos
- Writing drafts for print, websites, and social media
- Translating text into multiple languages
- Printing and producing materials
- Procuring ancillary supplies and equipment
- Global fulfillment
Ideally, working backward from the target date and building in time for each activity should lead to a reasonable start date for a project. But in the real world, we often don’t have full control over when to start.
Keeping the Best Laid Clinical Trial Timeline Plans from Going Awry
In the realm of life science research, start dates are typically dictated by protocol approval, purchase order initiation, or some other “go forward” activity. This means that an “ideal” clinical trial timeline needs some tweaking to make it conform to the real world’s start and end dates.
Typically, the time allowed for each individual activity needs to be adjusted—and most often compressed where possible—to meet aggressive deadlines. For a project manager, this can feel like trying to cram a 1-hour movie into a 10-minute time slot. While making those adjustments, the project manager must anticipate and avoid any potential dangers that could arise when trimming minutes and hours. The team must never, for example, skip steps or compromise quality to meet a deadline. The need for speed is understandable, but ultimately, getting it right is more important than getting it fast.
So, what happens when a request for a tighter deadline threatens to put quality at risk? “We never compromise quality,” says Sian Lukaszewicz, Imperial’s creative and language services manager. “One approach we use is to break deliverables into smaller chunks. For example, we can separate patient recruitment materials from retention materials, as the recruitment pieces often require more review and are needed sooner.”
Getting all teams on the same page is another project management challenge. “We achieve this with kickoff or alignment meetings, regular updates, and clear and concise instructions to all teams,” says Lukaszewicz. “Client teams receive specific timelines and dates for completing and returning their reviews. This keeps the project on track.”
Project Managers are Timeline Specialists
For projects with multiple components—such as medical writing, design, translation, printing, and shipment—a full-service provider can perform all of these functions to maintain consistency in quality and control over all timelines. Their experienced project managers coordinate all the talent and resources needed to produce such a wide array of deliverables and are worth their weight in gold. Project managers stay on top of all the details and timelines and ensure that communication occurs smoothly and with a level of transparency to their clients. Their role is absolutely critical to the success of the process.
The project manager also ensures accountability for activities. This is so internal team members and clients understand their roles and perform their assigned tasks on time to meet the ultimate target. By having a beginning-to-end understanding of all the steps and everyone’s role, the project manager steers the timeline to completion and provides clients with a smooth, hassle-free process.
The Imperial Advantage
At Imperial Clinical Research Services, we assign experienced project managers to oversee the entire process from initial concept to final delivery. When circumstances conspire to make clinical trial timelines extra challenging, Imperial’s dedicated project management pros apply creative thinking and the value of their experience to find solutions. “A detailed project management plan, clear timelines, and good communications with all teams are the key ingredients for success,” says Lukaszewicz. “Our goal is to lead our teams in navigating urgent and often moving targets to meet our client’s needs on time, every time.”