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 development on track.
We set up every protocol for your success by quality checking for internal consistency and accuracy and designing protocols for flexibility and adaptability to stakeholder feedback. Our experience means all our protocols are informed by subject matter and statistical consultants, as well as grounded in therapeutic insight to ensure clinical relevance.
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 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
Short-form overviews and CPT-compliant synopses that support submissions and internal decision-making. - Protocol Elements Documents (PEDs)
Capture all trial components early to guide stakeholders and streamline downstream processes. - Schedule of Activities (SoA) Tables
Visually mapped procedures, visits, and assessments for operational clarity and better 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.