EXPERTISE AND INNOVATION IN EVERY CLINICAL PROTOCOL DEVELOPMENT

Study design is a frequently misunderstood cornerstone of a trial protocol, which goes beyond defining the study type (randomized, observational, etc.) and the study arms. Our experts collaborate with you to design the participant journey, ensuring that the timing and methods of data collection accurately reflect each participant's CRF.

Our expert biostatisticians can perform sample size calculations for your study. Additionally, if you are unsure of the effect size to be used for the sample size calculations, we offer systematic literature reviews to inform and guide your decision-making process.

Adaptive clinical trials are getting increasingly prevalent. With years of experience, our team specializes in designing and writing the statistical sections of trial protocols, incorporating adaptive trial designs. Even if you are not thinking about adaptive design, it may save time and money in the long run.

Study design is a frequently misunderstood cornerstone of a trial protocol, which goes beyond defining the study type (randomized, observational, etc.) and the study arms. Our experts collaborate with you to design the participant journey, ensuring that the timing and methods of data collection accurately reflect each participant's CRF.

Our service covers the definition of study objectives and endpoints, study design, determination of data collection methodology and timing, sample size determination, writing or consulting on the statistical considerations, and implementing adaptive trial design. Apart from that, our protocol development service ensures compliance with regulatory standards, and quality assurance measures.

Our team excels in all aspects of protocol design and development, including familiarity with relevant FDA, EMA, and ICH guidelines, as well as best practices and recommendations found in reputable industry and academic publications. We integrate the latest compliance requirements into every protocol we develop.

Absolutely! Protocol development in general cannot be organized into a one-size-fits-all approach. We work with you to tailor this service to the unique requirements and challenges of your individual clinical trial. Contact us so we can discuss your specific needs.

While we streamline the protocol creation process, significant time and cost savings are realized when the protocol aligns outcomes and endpoints with the schedule of assessments. Additionally, aligning the schedule of assessments with data collection instruments further enhances efficiency. Moreover, ensuring alignment with statistical considerations optimizes the overall process. This especially reduces time and costs from conception, initiation, conduct, close out, and final reporting.

Participant safety goes well beyond collecting adverse events and SAE reporting in a regulatory compliant manner. The careful definition of endpoints, study design, schedule of activities, sample size, and statistical considerations all contribute to participant safety. The most unsafe situation for participants is to be exposed to experimental treatments when the study has no chance of success due to poor design or poorly calculated sample size.