Clinical Trial Start-Up Activities | Remington-Davis

Selecting the right research site is one of the most important decisions in a clinical trial startup. A well-chosen site does more than just provide a location—it serves as a strategic link to a partnership that streamlines operations, expedites approvals, and keeps patient enrollment on track.

Clinical trial startup is a complex process involving contract approvals, IRB submissions, patient recruitment plans, prescreening, feasibility, study staff training, vendor management, and patient and provider engagement—each of which can introduce delays if not managed efficiently. The right site offers efficiency for every phase, activating trials faster and moving swiftly toward execution.

Site Selection: The Foundation of a Successful Startup

Every clinical trial starts with site selection, but this choice extends far beyond just finding a site with available space and equipment. A well-qualified site must have:

• A proven track record of rapid study activation – Delays in startup can cost sponsors millions in revenue, making experience with fast activation critical.
• Regulatory expertise – Sites with in-depth knowledge of IRB submissions and local regulations prevent administrative bottlenecks.
• An engaged and diverse patient population – Without access to the appropriate patient population, patient enrollment stalls before the trial even begins.
• Established technology and infrastructure – Sites with eSource, CTMS, and remote monitoring capabilities improve compliance and data collection accuracy.

Key Clinical Trial Start-Up Activities & How the Right Site Keeps Them on Track

A site’s ability to streamline startup activities directly impacts activation timelines. Here’s how the right site can help:

1. Contract Approval & Budget Negotiations

Contract delays are one of the most common reasons clinical trials fall behind schedule. A strong site will:

• Proactively negotiate budgets to align financial expectations early.
• Ensure rapid legal review of a clinical trial agreement to prevent back-and-forth negotiations.
• Have an experienced legal team familiar with industry-standard contract terms.

Without an efficient site: Contract negotiations can stall for months, delaying site activation and increasing costs.

2. IRB Submission & Regulatory Approvals

IRB approvals are a critical regulatory checkpoint that must be cleared prior to patient recruitment. A site with strong regulatory expertise will:

• Submit complete, error-free documents to avoid IRB rejections.
• Engage with IRB contacts proactively, answering questions quickly.
• Utilize electronic submission systems to track approvals and maintain compliance.

Without an efficient site: Incomplete submissions or delayed responses to IRB inquiries can push back study activation by weeks or even longer.

3. Patient Identification, Prescreening and Enrollment

At the risk of stating the obvious, without patients, a trial cannot proceed. The right site has the tools and experience to identify, recruit, and enroll participants efficiently:

• Access to a diverse and engaged patient database accelerates recruitment.
• Dedicated recruitment teams ensure outreach is targeted and effective.
• Flexible scheduling and decentralized trial capabilities improve accessibility.

Without an efficient site: Enrollment targets may not be met, requiring costly protocol amendments or site expansions.

4. Patient Activation & Retention

Enrolling a patient is just the first step—keeping them engaged is equally important. A patient-centric site will:

• Provide clear education and onboarding so participants understand expectations.
• Offer support services like transportation and flexible scheduling.
• Use engagement tools to maintain communication and adherence to the clinical trial protocol.

Without an efficient site: High dropout rates can compromise data integrity and require additional recruitment efforts, delaying trial timelines.

What Makes Remington-Davis a Good Choice

At Remington-Davis, we specialize in efficient, patient-centric clinical trial startups. Sponsors and contract research organizations (CROs) trust us to:

• Activate trials efficiently with streamlined processes
• Navigate regulatory documents and approvals with precision
• Fulfill patient enrollment using our extensive, pre-screened database
• Reduce dropout rates with personalized patient support and engagement strategies from our site staff

When you partner with Remington-Davis, you will have a strategic partner committed to driving trial success from day one.

Launch Your Next Study Faster With RDI

A clinical trial startup is only as strong as the site leading it. With Remington-Davis, sponsors and CROs eliminate inefficiencies, reduce delays, and accelerate the activation process.

Optimize your next trial startup with an experienced team. Contact us today to learn how we can help.

Frequently Asked Questions

How can I search for the right clinical trial site to support a smooth startup?

Finding appropriate sites requires an understanding of factors like site performance metrics, regulatory expertise, patient recruitment capabilities, and retention rates. Sponsors should look for sites with a track record of fast activation, access to a diverse patient population, and strong infrastructure for electronic data management. On-site visits are also an important factor in gauging a site’s infrastructure and capability.

What clinical trial startup information should be included in regulatory submissions?

Regulatory bodies require complete and accurate information at every stage of clinical trial startup to avoid approval delays. Essential submission documents typically include the study protocol, investigator brochures, informed consent forms, site selection criteria, and patient recruitment strategies. A well-prepared study site ensures all necessary documentation is submitted error-free and on time.

How can working with a digitally-savvy site help prevent data access issues?

Sites that utilize advanced clinical trial management systems (CTMS) and electronic trial master files (eTMF) minimize the risk of data loss that could delay study activation. With real-time data access, automated backups, and secure digital infrastructure, a tech-forward trial site keeps study startup activities running smoothly and stakeholders aligned.