Study Designand Protocol Writing
A well-conceived protocol is the cornerstone of clinical trial success. Our Study Design and Protocol Development services integrate scientific expertise, therapeutic insight, and regulatory strategy to deliver protocols that are robust, submission-ready, and operationally executable.
Our service includes
Study Conceptualization and Clinical Development Planning
Translating clinical hypotheses into structured study designs aligned with therapeutic targets, operational feasibility, and regulatory requirements.
Protocol Writing and Scientific Justification
Drafting comprehensive, GCP-compliant protocols, incorporating strong rationales for study objectives, endpoints, eligibility criteria, statistical methods, and risk management.
Integration of Novel Trials Methodologies
Designing adaptive protocols, decentralized components (e.g., eConsent, remote monitoring), and real-world data integration strategies to optimize trial efficiency and patient centricity.
Regulatory and Ethical Alignment
Ensuring that study designs meet Swissmedic, Ethics Committee, and international (ICH-GCP) standards, facilitating smoother regulatory reviews and faster study start-up.
Supporting Documentation Development
Preparation of key ancillary documents such as Investigator Brochures (IBs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and Study Synopsis.
