Trials & Truths: Why Timelines Slip – and How to Keep Them on Track

AVION: Trials & Truths

Welcome to “Trials & Truths”, a new content series from Avion where we explore the realities of modern clinical research – the known obstacles, the hidden pitfalls, and most importantly, the solutions that ensure success. We’re here to shed light on the truths behind trial execution, because what’s often seen as “normal” in clinical trials doesn’t have to be inevitable.

In this inaugural post, we’re starting with one of the most common – and often misunderstood – topics in the world of clinical trials: “timeline slippage”

The Myth: Delays Are Just “Part of the Process”

We’ve all heard it before. Clinical trials are complex, and some delay is to be expected. While it’s true that no study operates in a vacuum – and there will always be external factors that influence pace – the idea that trial delays are unavoidable is a myth.

“At Avion, we’ve supported trials across oncology, dermatology, rare disease, neurology, immunology, radiopharma and nuclear medicine. Despite their varying complexities, one thing is consistent: timelines can hold when proactive strategy meets precision execution.”

But first, it helps to understand why they slip in the first place.

Common Causes of Timeline Delays

1. Underestimating Start-Up Complexity:Study start-up is rarely just one process. It’s dozens of overlapping mini-milestones: ethics approvals, regulatory submissions, site contracts, recruitment planning, and system configuration. Delay just one of these, and the entire timeline shifts.

2. Over-optimistic Recruitment Assumptions:Too often, projected enrolment numbers are based on ideal conditions, not real-world constraints. Sites may be enthusiastic but under-resourced. Patient pools may be smaller than expected. Without contingency planning, recruitment is the first domino to fall.

3. Poor Site Engagement:Sites that are technically activated but disengaged contribute little to recruitment and data quality. Site engagement isn’t a checkbox – it’s a relationship built over time with regular, meaningful contact and support.

4. Protocol Complexity:Complicated procedures or overly ambitious endpoints can discourage both investigators and patients. Every added burden increases risk of dropout, deviation, or disengagement.

Uncommon – But Impactful – Challenges

While the above are frequent culprits, we've also helped sponsors navigate more unusual hurdles:

• A dermatology trial where patient volume was high, but inclusion criteria clashed with local prescribing guidelines – slowing referrals until we worked with the sponsor to adjust criteria mid-study.

• A rare disease study where a flood affected two of the highest-performing sites – requiring rapid site transfers, emergency SOPs, and tight coordination to prevent overall delay.

• An oncology study in which an external vendor's EDC platform experienced unexpected outages during a crucial interim readout. Our data management team worked around the clock to extract and preserve CRFs using backup protocols.

These aren’t horror stories. They’re just reality – and they happen even in well-funded, well-designed trials. What matters is how you respond.

The Avion Approach: Planning, Presence, Partnership

Here’s where the “truth” in Trials & Truths really matters. At Avion, we know it’s not enough to react quickly. You have to anticipate issues before they escalate. Our approach is built around three principles:

1. Planning Beyond the Gantt Chart

Every trial begins with a plan. But at Avion, we go deeper – building scenario-based risk assessments that don’t just outline milestones, but account for real-world deviations. We stress-test protocols and proactively model bottlenecks before they become blockers.

“One of our most successful Oncology trials was delivered ahead of schedule because we had already factored in region-specific IRB nuances and built parallel workflows to accelerate site readiness. That only happens with a plan designed to flex, not snap.”

2. Hands-On Monitoring and Communication

Timeline protection doesn’t happen behind a dashboard. Our clinical operations team works directly with sites, often face-to-face, building rapport and solving challenges in real time.

“In one complex Radiopharmaceutical trial, weekly check-ins with our sites helped uncover early signs of recruitment fatigue. Within days, we adjusted the support materials and re-engaged staff – resulting in a 40% enrolment lift over the next two months.”

When you’re present, you’re proactive.

3. True Partnership with the Sponsor

Our clients don’t hire us to deliver checklists. They engage us to be their eyes, ears, and engine – and we take that seriously.

“We see ourselves as an extension of your team. Whether you’re a biotech firm running your first study or a pharma group managing global programs, we treat every project with the same intensity of focus. Because your success is our success.”

Delays Happen – But Direction Matters More

Let’s be honest: even the best-run studies can face headwinds. What defines success is not whether a timeline ever slips – it’s how your CRO identifies the early warning signs, communicates clearly, and works alongside you to recover momentum.

At Avion, we’ve never believed in “acceptable delays.” We believe in action, adaptability, and relentless pursuit of progress. Whether the issue is expected or unusual, common or rare – we work tirelessly to deliver the outcome our sponsors deserve.

So why do timelines really slip?

Because someone didn’t anticipate what was coming. Or didn’t act when it did.

But here’s the truth: with the right CRO, the right planning, and the right partnership, your trial can stay on track – or at least stay under control.

That’s the Avion difference.

Want to speak to a clinical operations expert about your next trial?

We’re ready when you are.

📩 Email: info@avionmedical.com.au

🌐 Web: www.avionmedical.com.au