Rescuing a Study at Speed to Ensure Trial Continuity

When a biotech company faced critical delays due to slow recruitment in Australia, the success of their Alopecia Areata clinical study hung in the balance. With the next phase of clinical trials at stake, Optimal Clinical Trials stepped in as a rescue site – and delivered exceptional results in record time.

The sponsor’s study faced unique challenges that threatened its progression:

• Slow recruitment left the trial at risk, requiring urgent intervention

• A compressed timeline and cost pressures demanded immediate action to turn things around

• The outcome of our work would determine whether the investigational product could advance to the next phase

As a Rescue Site coming on late in the study, our team understood the urgency and the high stakes. Rescuing the Alopecia Areata study at speed to ensure trial continuity became a key priority. With determination and care, we embraced the challenge and delivered outcomes that exceeded expectations.

1. High Quality Recruitment

Time was short, but our team’s agility and creativity ensured success. We:

• Partnered with specialists, peak bodies, key community groups, salons, wig manufacturers, and influencers to connect with individuals affected by Alopecia Areata.

• Leveraged our robust volunteer database to identify eligible participants quickly.

• Rolled out targeted multi-channel campaigns, including digital marketing, traditional outreach, and grassroots engagement.

Every participant was meticulously pre-screened by our dedicated patient engagement team to ensure alignment with the study’s protocol requirements.

2. Operational Agility

Rapid startup and flawless execution were non-negotiable. We streamlined our processes, secured swift approvals, and ensured operational preparedness. Our teams:

• Simulated workflows to anticipate challenges and refine performance.

• Created a participant-first experience with clear directions, complimentary refreshments, free parking, and transport assistance.

3. Transparent Sponsor Collaboration

Transparent communication was key. We engaged the sponsor with regular updates, ensuring alignment, confidence, and a seamless flow of information at every step.

4. Participant Engagement

By prioritising comfort and care, we fostered trust, which translated into unmatched retention.

Our coordinators ensured consistent, tailored communication with each participant, fostering trust and engagement throughout the trial. This focus on care and connection resulted in a 100% retention rate, with every participant completing their journey through the study.

This rescue study is a testament to Optimal’s ability to deliver under pressure, driven by performance, care, and expertise:

• Quick Turnaround: Our team’s swift decision-making, streamlined process, and adaptive approach enabled us to deliver a rapid startup and respond effectively under pressure, exceeding the sponsor’s goals.

• Participant-Centred Care: We prioritised participant comfort, engagement, and trust, leading to 100% retention.

• Proven Quality: Backed by our ISO 9001 certification and a recent successful FDA inspection, our processes delivered uncompromised data quality.

• Exceptional Performance: Surpassing recruitment targets and timelines solidified Optimal’s reputation as a leader in clinical trial delivery.

At Optimal Clinical Trials, we believe in transforming challenges into opportunities. We are a proven clinical trials rescue site, showcasing that with agility, care, and expertise, success is achievable.

Let’s connect and explore how we can set your studies up for success – no matter the challenge.