Tailored Program & Protocol Design
Set your study up for success with comprehensive trial designs. By incorporating insights from all key stakeholders, we design protocols that meet sponsor and regulatory needs while accelerating timelines.
- Protocols built to achieve trial goals
- Input from experienced statisticians and health economics teams
- Deep therapeutic expertise informs optimal trial design
- Innovative designs for efficient and cost‑effective trial
- Local teams optimize ethics and regulatory submissions worldwide
Seamless Clinical Study Start‑Up Solutions
Launch your study without delays with expert guidance on start‑up activities, from feasibility assessment and site selection to regulatory submissions.
- Local relationships drive rapid site identification and activation
- Global alliances with sites and investigators accelerate start‑up
- Continuous oversight from dedicated teams mitigates delays
- Highly experienced staff operating across the APAC region and beyond
- Access to proprietary technology automates site feasibility in the USA
Clear Communication for Transparent Trials
Stay informed and engaged with clinical trial start‑up processes that prioritize visibility and traceability throughout the design process.
- Centralized data management support removes redundancy
- Regular reporting of key communications, such as protocol amendments
- Real‑time issue resolution through dedicated support
- Comprehensive documentation for regulatory readiness
Expert Services Built for You
Whether your study is regional or global, we build our clinical study start‑up solutions on collaboration—pooling diverse expertise to optimize efficiency, reduce costs, and deliver quality results.
Through adaptive protocol designs, we support efficient trial start‑up and execution across every phase.
With a proven track record in addressing the complexities of late‑phase studies, we deliver solutions for even the most challenging trials.
Case Study
Patient‑First, From Design to Delivery
When delivering a Phase I oncology trial in a competitive recruitment landscape, we used our protocol design and clinical study start‑up expertise to achieve success within the sponsor’s tight timeline:
- Agile, adaptable study design enabled cohort expansion and dosing adjustments without delays
- Established site relationships supported rapid recruitment
- People‑first protocol design prioritized patient safety, minimized burden, and ensured comfort
In this early‑phase trial, our strategic study design reduced the burden on patients with advanced cancer, contributing to progress in developing new treatments.
See our impact in actionFrequently asked questions
What therapeutic areas do you specialize in?
We have diverse therapeutic expertise, with areas of excellence in renal, cardiometabolic, and oncology clinical research. Beyond these focus areas, we bring proven capabilities in respiratory, neurology, endocrinology, medical device trials, and more—delivering innovative, patient‑centered solutions across all our work. See Therapeutic Expertise for more information.
How do you optimize protocol design and clinical study start‑up to ensure feasibility, efficiency, and impactful results?
We take a collaborative approach to protocol design and implementation, combining biostatistics expertise with insights from health economists, in‑practice clinicians, and relevant key opinion leaders. This allows us to design practical, resource‑conscious protocols aligned with trial goals.
Our established alliances with coveted sites and investigators span 70+ geographies, supporting efficient clinical trial start‑ups across the APAC region, Europe, and the USA.
Can you support the regulatory aspects of protocol design and clinical study start‑up?
Yes, we provide comprehensive support for the regulatory aspects of protocol design and study start‑up. Our team ensures your trial meets all regional and global compliance requirements, manages ethics submissions, and liaises with authorities to streamline approvals.
What steps do you take to ensure compliance with evolving regulations?
We monitor regulatory changes globally, adapting strategies to maintain compliance and continue to deliver robust protocol designs and clinical study start‑up services.
Our dedicated team stays updated on evolving standards, liaises with local authorities, and proactively adjusts documentation, processes, and timelines so you can be confident that your trial aligns with the latest requirements in every region.
Related Services
Patient Recruitment
Accelerate recruitment and boost retention through our established global alliances with trusted sites and investigators, including a strong APAC presence.
Project Management
Drive clinical research success with our experienced project management team, seamlessly coordinating functional areas and vendors across the trial lifecycle.
Clinical Trial Monitoring
Ensure trial success with expert monitoring and site management, safeguarding data integrity and patient safety through local expertise and oversight.
Medical Writing
Get accurate, compliant documentation for every trial. We combine local expertise with a global perspective to deliver success, from protocol development to regulatory submission.