Why a Well-Developed Protocol Matters

The clinical trial protocol governs all aspects of trial execution at the clinical site. A well-designed and clearly written protocol is crucial for:

• Communicating critical trial elements to investigators, study staff, IRBs, and regulatory authorities.

• Ensuring high-quality science and robust data collection.

• Accelerating trial development and completion.

• Maintaining regulatory and data compliance.

• Assisting trial teams in making difficult decision

Our Expertise

Medical Writers

Yayasan RPRI’s protocol development teams are composed of experienced professionals including medical writers, clinicians, biostatisticians, and clinical operations staff. Our teams collaborate to deliver scientifically and logistically excellent protocols for phase 1 to phase 4 trials.

Biostatisticians

With a robust background in clinical operations, our team reviews and contributes to protocol design, ensuring feasibility and quality data collection. Our leadership in clinical operations has decades of experience managing regional CRAs and data management professionals.

Clinical Operations

Our team of medical writers brings extensive experience in regulatory writing, ensuring that each protocol is clear, concise, and compliant with ICH and regulatory authority requirements.

Clinicians

Our biostatistical staff provides expert consultation on study design, sample size estimation, and statistical methodologies. We specialize in both traditional and adaptive trial designs, offering the specialized guidance needed for innovative study protocols.

Our team of experienced clinicians provides important expertise in medical related decisions ensuring the trial is designed in the safest way for patients.

Our Promises

Protocol Authoring

Developing comprehensive and precise protocols from sponsor-provided background information.

Regulatory Compliance

Ensuring protocols meet all ethics standard and regulatory authority requirements.

Statistical Consulting

Offering sample size estimation, study design consultation, and statistical section development.

Clinical Feasibility

Reviewing and contributing to protocol design to ensure practicality and high-quality data collection in the field.

Commitment to Quality

Our rigorous approach to protocol development ensures that your clinical trials are scientifically sound and regulatory compliant. We work closely with sponsors’ experts and our network of principal consultants to create protocols that are both clinically feasible and designed to collect meaningful data.