Delays can be small or big, from minor misfortunes that make us late for dinner to major study setbacks that mangle study timelines and jeopardize study goals. While delays in life are expected and inevitable, clinical study delays don’t have to send a trial off track.
My flight departure from the U.K. to Spain was dramatically delayed due to an incredible amount of rain at the destination, causing localized flooding. Then, once in the air, the plane experienced turbulence due to winds from the same storm system! As we bounced our way south, I found myself thinking that delays are a given in life.
My destination was the SCOPE Europe Conference in Barcelona. Like many of our colleagues attending clinical trial conferences, we rely on a chain of shipping companies, vehicles, and highways for the safe and on-time arrival of our booth components and support materials. Not to mention the flights or other transportation needs to get our personnel safely to each event.
We experienced this firsthand last month when we attended the SCRS Site Solutions Summit in Miami. On arrival at the exhibit hall, we discovered a crucial piece of our booth stand was missing. However, the event crew stepped in and configured a solution to get us ready in time. Potential delays were averted, so it was on with the show!
Clinical study delays
We spoke with multiple contacts over the course of the three days in Barcelona who shared the pain points they have heard from their research site teams and project leads. This includes:
- Unexpected clinical study delays with site activation causes a huge knock-on impact, resulting in budget increases and missed timeline targets.
- Recruitment: Failing to recruit the numbers of patients needed, and worse still, a high screen fail or attrition rate.
These issues cause frustration and stress for all involved over the short term, as well as the long term of the study. Fortunately, we specialize in working in partnership with our clients to resolve and mitigate gaps and challenges head-on. (Study startup challenges are a frequent topic of my colleague Dan McDonald’s blog posts.)
The mindset that delays are inevitable isn’t enough. Our skilled project managers always work time into the schedule to accommodate unexpected delays. Yes, it’s smart to plan for the unexpected.
Ancillary supplies and equipment
Start Early
Another struggle shared was getting the right ancillary supplies and equipment to sites on time. It’s essential to start early in the clinical study process to determine and procure the supplies and equipment needed for your study.
Starting early allows time for unexpected delays, such as compatibility testing, alternative supplies/equipment needs due to individual country regulations, or supply chain issues that appear without warning, like weather events or regional conflicts.
Imperial is always happy to step in to help sponsors and CROs stay on top of this. Protocol compliance, global complexities, and international shipping are Imperial’s specialties.
When it comes to ancillary supply and equipment needs, we provide:
- Purchase and rental options
- Expert kitting, including (but not limited to) lab kits, site-based kits, field-based kits, and at-home study visit kits
It all boils down to expertise: Imperial’s supply, equipment, and logistics experts can support your study from the planning phase or ride in like the cavalry with solutions later when needed.
Meet study startup goals
Our week of travel continued last week with further meetings and events in London and Dublin. These events were entirely reliant upon our attendance and scheduled within tight windows of time. Whilst the tension and stress this occasionally creates can be complex to navigate at the time, the satisfaction at the end of a successful week, when you have achieved your goals despite any challenges you face, is immense. And, for me, this resonates again with how many times this occurs during study startup.
The show must go on. The trial continues, and milestones must be met. And the patients at each site need to continue to receive treatment and care, some for critical reasons. Understanding how to plan for and prepare to prevent clinical study delays within this increasingly complex global world of clinical trials is where we excel.
Putting it in perspective
Whilst our travel and conference this week were impacted by the heavy rain in Spain, our event continued, and we returned to our normal lives. The burdens we faced were short and minimal, and those delays were soon forgotten.
But many in Spain, particularly in the Valencia region, haven’t been as lucky. Many patients attending sites across the region face devastation at home and still desperately need to access hospitals and sites in a city dramatically impacted by flooding. Our thoughts and prayers go to all involved.
The Imperial Advantage
I hope you get a chance to work with Imperial and see us in action. Our approach is to exceed expectations, and I believe your interaction with Imperial and our fabulous team will leave you with a great experience. Don’t wait too long – contact us today!