It's no wonder scientists begin clinical trials with great excitement: combine promising discoveries with the best test sites, scientists, and as many qualified, willing patients as possible, and off you go to hypothesis validation.
Along the way, however, even the best drugs and devices hit roadblocks.
Like a manned space mission, every clinician needs near-flawless program execution, before and after launch. And, of course, mistakes can be dangerous.
The complexity of clinical trials means many obstacles involving people, technology, and data. When you're focused on your own trial, you can't always see all potential obstacles.
That's where a life sciences consulting firm can help.
Below are four real-life examples of obstacles to clinical trial success commonly faced by drug and device companies. As you'll see, in each case, a life-sciences consulting company provided on-time, vital assistance.
Management Conflict
Due to the complexity of trials, biotech companies may be tempted to assign more managers. Still, problems can arise when each leader pushes to achieve their own goals while disregarding the project as a whole.
When everyone is a leader, no one is in charge, and the trial itself suffers. Managers can conflict on how to interpret study protocols and data. The resulting lack of leadership bogs the process down. In this competitive, ‘too many cooks in the kitchen' scenario, only the loudest voices get heard, and significant concerns go unaddressed.
Often the solution to this puzzle is an experienced, fresh set of eyes. A third-party project manager can facilitate communication, re-balance power, and provide much-needed direction.
The Knowledge Loss That Comes with Personnel Turnover
While project managers are vital to success, they're also human beings with career aspirations like the rest of us. Is there anyone on your team you couldn't afford to lose mid-development? When it happens, companies watch a wealth of knowledge walk out the door.
In a sense, this project challenge is the opposite of the one discussed above. Instead of too many bosses, you have one person so valuable that their loss would be devastating. Is your project one two-week notice away from failure?
While no company wants to lose its best talent, there's almost no way to prevent it. To mitigate risk, partner with a life-sciences consultant with the strategic resourcing ready to fill-in. Skilled at picking up and leading projects at any stage, the right management provider can ensure your trial stays on track.
Informatic Arrest
Whether it's a LIMS, ELN, or SMDS, there are a variety of systems integral to collecting and managing trial data. As these systems grow in sophistication, so can their complexity.
For example, you may need to use a LIMS and an ELN in concert to obtain the data you need for your trial. The challenge is that these systems are not always compatible, making the processing and reporting of study findings tedious and time-consuming.
When designing your trial procedures, give careful consideration to the compatibility of the systems involved. While specific features may pull you to one platform over another, don't forget to consider interoperability. A qualified consultant can provide you the integration you need in a timely fashion, or source the right software from the start.
Mishandling of Samples
Even the brightest, most-engaged HCPs can mishandle samples or test results – sometimes without being aware. How many products suffer from difficult questions about data collection either at the time of FDA review or in post-marketing?
Lab robotic systems can improve your clinical operations at the site level, in a way unattainable by scientists. When sample handling, storage, and testing are managed by automated systems, the risk of inconsistent or invalid results diminishes.
Software Implementation Emergency
The success of your trial depends on the quality and availability of data. It's the primary reason manufacturers invest in sophisticated software systems.
Still, as we all know, the implementation of sophisticated software doesn't always go to plan. Even if you choose the best platform, the vendor may lack the resources to customize it for your operation.
A life sciences consulting firm can bring the expertise that even a software vendor lacks. That way, your technical personnel can concentrate on supporting your existing applications, and your trial moves forward.
Partner With ProPharma
Developing tomorrow's blockbuster drug has never been more challenging These four common pitfalls have delayed and even ruined many clinical trials.
Before your trial can hit an unforeseen obstacle, taking down months (or years) of dedicated clinical research, why not partner with a comprehensive life sciences firm like ProPharma? Feel free to call us at 877-808-5675 or let us know your needs in our online form and the right specialist will reach out to you.
Our expert staff offers a wide variety of global consulting and solutions to meet the needs of your trial. And our business relationships provide us with a wide base of knowledge. From discovery to approval, ProPharma can ensure your next life-changing therapy comes to fruition.
