StudyDesign and 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.
At GALSER, we build protocols not only to satisfy regulatory expectations but to anticipate the operational realities of modern clinical research - accelerating your study’s pathway from concept to execution.
Feedback from our clients
“GALSER team has shown a great mix of professionalism, flexibility/adaptability and profound knowledge of the human research landscape in Switzerland”
01
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“We were impressed by GALSER’s strong relationships with the study sites and their ability to keep things moving despite the usual challenges. It really helped us stay on track”
02
/05
“A remarkable project leader who managed to deliver a high-quality protocol in a very short time”
03
/05
“The GALSER team guided us through the Swiss regulatory process with clear advice and great responsiveness. Their support made the entire submission much easier than we anticipated.”
04
/05
“Your level of detail and expertise really stand out. It’s been a real pleasure working together!”
05
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