Study Start-Up

An integrated, technology-enabled approach to drive improved efficiency and quality across the entire clinical development program.

A solid foundation for study success

When your future rests on the outcome of a study, you need a dependable platform for an effective trial launch. Premier Research begins with our expert global team, then adds proven processes and innovative technologies to deliver smart study start-up — with no wasted time or money.

Our people are what make the difference when it comes to ensuring every piece falls into place. One dedicated lead oversees every aspect of your global trial, driving timelines, preparing core documents, planning for regulatory reviews — and providing one point of contact to address all your questions.

Study start-up tailored to your study’s specific needs

From identifying the sites to compiling the core clinical regulatory packages, a dedicated study start-up team supports your effective project launch. Our work is guided by consistent processes, consistent oversight, and consistent accountability.

No mirroring structures required; our subject-matter experts handle each key start-up activity, then unify their output in a comprehensive package
Clear-cut Standard Operating Procedures (SOPs) ensure constant high quality across deliverables and projects
Flexible setup reflects your study’s unique priorities

Transparent, real-time access to all start-up activities

Our Study Start-Up application — part of the PremierOne Ecosystem — automates the collection of all trial-related data, then applies workflow optimization to decrease cycle times and compress timelines. That helps us easily navigate through data to identify the most urgent tasks, keeping even the largest global studies moving smoothly across dozens of sites in multiple countries.

Task automation streamlines workflows and responsibilities, slashing manual work and duplicated efforts
Centralized activity and document tracking supports collaboration across teams
Integrated system applies critical path methodology to help with prioritizing assignments and removing roadblocks to meet deadlines, ensure consistency and simplify follow-up
Built-in templates reflect our team’s vital in-country regulatory knowledge, simplifying compliance with one click

Part of our Study Start-Up application, PremierPredict™ is a powerful clinical trial enrollment probability simulator that we use to deliver more structured, efficient planning for country and site activation and patient recruitment – not just at the initial stages but throughout the full course of your project.

Alleviates uncertainty and delivers successful on-time clinical trials
Delivers more accurate patient recruitment projections more quickly with calculated mapping for each country, site, and patient
Enhances decision-making with visualizations, detailed numbers, and project milestones
Ensures your development program stays on track with the ability to remodel enrollment projections as needed throughout the study

Alleviates uncertainty and delivers successful on-time clinical trials
Delivers more accurate patient recruitment projections more quickly with calculated mapping for each country, site, and patient
Enhances decision-making with visualizations, detailed numbers, and project milestones
Ensures your development program stays on track with the ability to remodel enrollment projections as needed throughout the study

VIDEO

Premier Study Start-Up

Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed the PremierOne Ecosystem to create a paperless, electronic data process, start to finish.

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PREMIER PERSPECTIVE

Ensuring compliance with GDPR

At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blog post, we focus on four GDPR articles that are relevant to study start-up.

Related Services

Study start-up is part of a wide range of service offerings that include regulatory consulting, project management, and data management. Follow the links below to learn more about how clients gain from our specialized expertise.