+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 approaches are backed by standardized literature and correspondence, providing a solid foundation for successful regulatory submissions.
Empower Your Clinical Trials with Expert Clinical Development Services and a Strategic Development Plan
At COD, we specialize in delivering comprehensive Clinical Development Services that pave the way for successful trials and regulatory approvals. A well-coordinated plan enhances efficiency and reduces risks in collecting essential clinical data, ensuring both patient safety and product efficacy.
Regulatory Strategy & Planning
Protocol Development
Our Protocol Development services specialize in creating comprehensive patient-centric study protocols, subject information sheets, consent forms, patient diaries, and investigator brochures that prioritize patient needs while aligning with scientific and regulatory objectives.
Our experts carefully monitor regional practices to define accurate endpoint selection criteria, ensuring that all documentation remains relevant and precise. This scientifically robust approach ensures protocols are tailored to the patient population, improving study credibility and the overall success of clinical development.
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 contribute significantly to Protocol Development, including eligibility criteria, ensuring robust and effective study frameworks that strengthen Clinical Development Services.
Additionally, we provide expert advice on the rescue medication process, enhancing patient safety and study integrity.
Statistical Planning
With our expertise in Statistical Planning, we support clients in defining primary and secondary objectives that align with scientific and regulatory requirements, designing methodologically sound studies such as randomized controlled trials, observational studies, or other models.
Our team determines the appropriate sample size for clinical trials to ensure sufficient power to detect true effects while minimizing Type I and Type II errors. We also apply advanced statistical methodologies such as ANOVA, Linear Regression for continuous data, Logistic Regression for categorical data, and Survival Analysis, including Kaplan-Meier curves and Cox Models, ensuring accuracy and reliability of trial outcomes.
Request for Proposal
Partner with us to confidently navigate the complexities of Clinical Development Services. We help transform innovative ideas into successful therapies that improve patient outcomes. For more details or to discuss your specific requirements, connect with us today.