Clinical Trial Protocol Development & Amendments Services
Build stronger trials from the start with protocols designed to reduce risk.
A well-designed protocol doesn’t just need to meet regulatory expectations, it lays the foundation for a smoother, more efficient clinical trial. At QInscribe, we help you get it right from the beginning, reducing costly amendments and keeping your study on track.
We design every protocol for success through rigorous quality checks for internal consistency and accuracy, while ensuring flexibility to adapt to any stakeholder feedback. Each protocol benefits from the combined expertise of subject matter experts and statistical consultants, and is informed by our deep knowledge of the therapeutic area to ensure the trial design is both meaningful and relevant.
End-to-End Protocol Support
Whether you’re preparing for a new trial or revising an existing plan, we offer comprehensive support across all protocol development stages.
- Protocol Conceptualisation
Shape your study with the right scientific questions, endpoints, and methodology, aligned with regulatory guidance. - Protocol Writing
Full development using ICH M11 based template or TransCelerate’s Common Protocol Template or your preferred format, tailored to your study phase and therapeutic area. - Protocol Amendments
Well-documented updates with clear change histories, ensuring compliance and reducing back-and-forth with regulators. - Protocol Synopses
Concise overviews structured to follow recognised clinical protocol templates which ensure regulatory expectations, and support both submissions and internal decision-making. - Protocol Elements Documents (PEDs)
Comprehensive early-stage documents that define all trial components, aligning stakeholders and ensuring a smooth transition into full protocol development, regulatory submissions, and trial start-up activities. - Schedule of Activities (SoA) Tables
Clear, visually mapped schedules outlining procedures, visits, and assessments with appropriate footnotes to enhance operational clarity and strengthen site engagement.
What You Gain by Partnering with QInscribe
Confidence in Regulatory Submissions
Ensure your protocol meets global regulatory and ICH standards to ensure a successful submission.
Clear, Persuasive Communication
A robust protocol minimises mid-study changes and supports faster ethics and regulatory approvals.
Less Administrative Burden
Offload the heavy lifting of protocol drafting, formatting, and revisions to our experienced medical writer who takes advantage of our AI tools, freeing up your internal resources.
Smarter Study Design
We help align your protocol with your scientific objectives and operational realities, ensuring feasibility from day one.
A Scalable Solution
Support one document or an entire portfolio, our services flex around your needs and timelines.
Need support with an upcoming trial?
Let’s help you create a protocol that sets your study up for success – efficiently, accurately, and with full regulatory confidence.