Study Start Up

When your future rests on the outcome of a study, you need a dependable team of experts for an effective trial launch. At Premier Research, we bring together an experienced global team, proven processes, and innovative technologies to deliver smart study start up and flawless competent authority (CA) and ethics committee (EC) maintenance to ensure trial success at every step—without wasted time or resources.

Precision Country Selection

A successful trial starts with selecting the right mix of countries and then identifying the sites best positioned to enroll the patients you need. Our expertise in global feasibility and site selection helps ensure both decisions are driven by strategy, not assumptions.

The first step is determining where your target patient population can most effectively be reached. Beyond patient availability, we evaluate the regulatory landscape, standards of care, competitive trial activity, and other facts that can influence study timelines, patient enrollment rates, and trial outcomes. This approach helps identified countries best suited to your program, rather than defaulting to regions with the highest volume of clinical research activity.

To support these decisions, our medical informatics team uses a number of commercial databases to analyze key trial success factors based on the entire clinical landscape. We analyze global patient prevalence, variations in standard of care, competing studies, and potential regulatory challenges to build a country strategy grounded in data.

Site Identification for Optimal Trial Outcomes

Once countries are selected, each trial is assigned a Site Intelligence and Strategic Engagement Analyst to oversee the identification, evaluation, and selection of sites for your trial. This process is powered by our Remarque® Contacts module, a comprehensive database tracking site capabilities, investigator performance, and institutional data.

In addition, Premier leverages established partnerships with site networks under master confidentiality agreements and pre-negotiated contract templates to accelerate start-up and enable cost savings. By combining data-driven insights with deep relationships, we recommend the most qualified and reliable sites to ensure a successful trial outcome. This data-driven approach enables smarter decisions from the outset.

Strategic Trial Management From Start to Finish

To further ensure seamless execution, each trial is assigned specialized leads to manage critical trial functions:

• Site Contracts Lead oversees contract and budget negotiations between sponsors and sites, ensuring preferred terms are met. 
• Regulatory Submissions Lead guides CA/EC submission strategy, streamlines documentation, drives timelines, and acts as a single point of contact for all your global CA/EC questions.

Tailored Study Start Up for Your Specific Needs

Every study is different, which is why we offer a flexible, yet structured approach, guided by consistent processes, oversight, and accountability. From identifying the sites to compiling the core clinical regulatory packages, a dedicated study start up team supports your effective project launch.

Our process is defined by:

• Robust, Active Investigator Database comprised of sites and site networks with established performance history and pre-qualified study participation capabilities
• Site Identification Kick Off Meeting and Regulatory Study Start Up Plan (RSSP), which document a flexible setup reflecting your study’s unique priorities and provides a blueprint for your start up success
• Clear Standard Operating Procedures (SOPs) to ensure constant high quality across deliverables and projects
• Comprehensive CTMS Tracking that aggregates the work of our local subject-matter experts so that the Regulatory Submissions Lead can track key study start up activities through the handoff to CRAs and Clinical Leads as sites approach activation

Real-Time Transparency and Workflow Optimization

We use our Remarque® Study Start Up module to standardize the collection of all trial-related data, streamline workflow, and optimize efficiencies to minimize cycle times and compress timelines. This integrated system helps us easily navigate data to identify the most urgent tasks, keeping even the largest global studies moving smoothly across dozens of sites in multiple countries.

• Track activities and documents centrally for seamless collaboration across teams
• Apply critical path methodology to help prioritize assignments and remove roadblocks to meet deadlines, ensure consistency and simplify follow-up
• Leverage built-in templates that reflect our team’s vital in-country regulatory knowledge, simplifying compliance
• Forecast site activation and project patient enrollment during start up and through the entirety of a trial to keep your study on track

A Trusted Partner

With Premier Research, you gain a trusted partner committed to accelerating your study start up while maintaining the highest quality standards. Let’s move your research forward—smarter, faster, and with confidence. Contact Premier today to discuss the best way to advance your study.