Clinical SOP Development Services
Establish clear, compliant, and effective Standard Operating Procedures.
At QInscribe, we recognise that Standard Operating Procedures (SOPs) are critical to the success of clinical trials. SOPs ensure safety, consistency, and regulatory compliance across every phase of clinical research. Our SOP Development service is designed to support pharmaceutical, biotechnology, and CRO organisations in building a strong operational foundation that fosters highly efficient internal processes and audit readiness.
Whether you are launching a new trial, scaling operations, or aligning with updated regulatory expectations, our expert medical writing team collaborates with you to develop SOPs that are clear, customised, and compliant with international standards.
Our SOP Development Solutions Include:
- New SOP Development
The creation of new SOPs based on your organisation’s processes and operational requirements. - Custom SOP Development
With unique characteristics and niche focuses within your organisation, we can tailor your SOPs to whatever expertise your business may have across any therapeutic area or study specific protocol. - Expert Regulatory Knowledge
SOPs crafted to meet international compliance standards including ICH-GCP, FDA, and EMA expectations. - SOP Review & Optimisation
Evaluation and refinement of your existing SOPs to enhance clarity, operational efficiency, and compliance. - SOP Simplification
Streamline complex processes into more efficient and easy to follow steps, while upholding regulatory compliance. - SOP Harmonisation
Where SOPs may overlap or are cross functional, ensure alignment and consistencies across these documents. This is especially popular following merger and acquisition. - Gap Analysis & Risk Mitigation
Identification of procedural and documentation gaps with actionable recommendations for compliance alignment. - End-to-End Support
Guidance through SOP lifecycle stages—from initial drafting and stakeholder review to training, implementation, and ongoing improvement.
What You Gain by Partnering with QInscribe
Confidence in Regulatory Submissions
Our SOPs are written in alignment with ICH-GCP, FDA, EMA, and other global regulatory guidelines, promoting participant safety and seamless regulatory inspections.
Faster Turnaround Without Compromise
We design SOPs that ensure standardised and reproducible processes across your clinical trial operations, reducing procedural errors and variability.
Less Administrative Burden
Our comprehensive SOPs serve as effective training tools and ensure preparedness for internal and external audits.
Clear, Persuasive Communication
Our SOPs facilitate consistent data collection, source documentation, and reporting processes, enabling successful submissions and scientific credibility.
A Scalable Solution
Support one document or an entire range of SOPs, our services flex around your needs and timelines. Due to our internal efficiencies, we can manage large volumes of document creation with fewer internal resources.
Let’s simplify your path to submission.
We help ensure your clinical trial operations are compliant, efficient, and inspection-ready—so you can focus on bringing safe and effective treatments to market.