+91 79 6947 8900 
+1(732) 749-7719 We provide a comprehensive regulatory landscape analysis for your target markets (USFDA, EU, ROW, WHO, and DCGI) to ensure compliance with the latest guidelines and standards specific to your molecule. Our experts meticulously plan the regulatory pathway and milestones, detailing necessary submissions like IND and NDA, and creating a structured timeline for regulatory approvals. Additionally, we develop country-specific regulatory strategies that consider unique patient selection criteria to ensure compliance and efficacy. Our strategies are backed by comprehensive correspondence with standard literature, providing a robust foundation for regulatory submissions
Empower Your Clinical Trials: Start Early for a Strategic Development Plan
At COD, we specialize in crafting comprehensive Clinical Development Strategies that pave the way for successful clinical trials and regulatory approvals. A well-coordinated plan enhances efficiency and reduces risks in collecting essential clinical data to ensure the therapy’s safety and efficacy.
Regulatory Strategy & Planning
Protocol Development
We specialize in developing comprehensive patient-centric study protocols, subject information sheets, consent forms, patient diaries, and investigator brochures that prioritize patient needs while aligning with regulatory requirements and scientific objectives.
Our team of experts meticulously monitors regional practices to offer precise endpoint selection criteria, ensuring that all documentation is both relevant and accurate. This approach guarantees that our study materials are scientifically robust and tailored to meet the specific needs of the patient population, enhancing the overall effectiveness and credibility of clinical studies.
From Protocol to Practice: Ensuring Seamless Clinical Trial Execution
150+
Clinical Study Protocols and associated Pre-study documents
KOL Engagement
We leverage our extensive global network of Key Opinion Leaders (KOLs) to provide critical insights on study design, patient selection criteria, and endpoint validation. Our KOLs offer key inputs on protocol development, including eligibility criteria, ensuring robust and effective study frameworks.
Additionally, we provide expert advice on the rescue medication process, enhancing patient safety and study integrity.
Statistical Planning
We assist in articulating primary and secondary objectives that align with your scientific and regulatory goals, designing methodologically sound studies, whether randomized controlled trials, observational studies, or other designs. Our team also determines an adequate sample size for clinical trials to ensure sufficient power to detect true effects while minimizing Type I and Type II errors, considering factors such as expected effect size and significance level.
Additionally, we select detailed statistical methodologies based on data type and trial endpoints, using ANOVA or Linear Regression for continuous data, Chi-square tests or Logistic Regression for categorical data, and Survival Analysis, including Kaplan-Meier curves and Cox models, for time-to-event data.
Request for Proposal
Partner with us to navigate the complexities of clinical development with confidence. Let us help you turn your innovative ideas into successful therapies that improve patient outcomes. For more information or to discuss your specific needs, please contact us today.