COD Research

Comprehensive clinical development services delivering end-to-end clinical research, including strategic development plans, protocol development, regulatory strategy, KOL engagement, and statistical planning to pave the way for successful trials and regulatory approvals.

Pharmacovigilance services supporting the detection, management, and minimization of safety concerns for investigational and marketed products.

Expertise in Individual Case Safety Reports and literature support for clinical trials and post-marketing surveillance.

Advanced signal detection, validation, evaluation, and legacy data integration utilizing SAS-enabled quantitative analysis and physician-led qualitative analysis.

Comprehensive lifecycle safety, regulatory compliance, and risk management services for medical devices and combination products.

Comprehensive service portfolio offering regulatory insights and solutions for pharmaceutical and biologics regulatory compliance, drug development, submissions, and post-approval lifecycle management.

Professional case intake, EV WEB downloading, triaging, data entry, peer review, and physician/medical review of ICSRs.

Specialized medical safety services including aggregate reporting, signal management, and risk management.

EudraVigilance and non-EudraVigilance case processing covering spontaneous, non-serious, business partner, literature, and digital media reports.

Development of medical safety and risk management systems including core RMPs, EU RMPs, local RMPs, REMS, and additional Risk Minimization Measures (aRMMs).

Comprehensive project management services for clinical trials ensuring seamless, efficient, and high-quality project execution globally across diverse regions.

Specialized clinical research consulting services linking top-notch talent with world-class clinical teams for complex global projects.

Personnel sourcing model maintaining client team control while achieving high quality, continuity, and repeatability across clinical trial phases.

Quality Assurance (QA) services ensuring operations comply with industry standards, focusing on Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).

Real-world evidence studies using robust methodologies and diverse data sources to generate meaningful insights supporting regulatory submissions, market access, and clinical decision-making.

Adverse event and serious adverse event processing, SUSAR processing and submission, and AOSE preparation.

Biometric solutions featuring Clinical Data Management and Biostatistics to boost efficiency, accuracy, and compliance throughout clinical trials.

Clinical trial operations service focusing on streamlining study start-up processes, conducting site feasibility assessments, and selecting sites aligned with study goals.

Comprehensive consulting, audit, and compliance services designed to maintain the highest standards of Good Clinical Practices (GCP) for clinical trials.

Creation of comprehensive patient-centric study protocols, consent forms, patient diaries, and investigator brochures.

Medical safety services including periodic safety listing review, line listing reports, risk management strategies, and Development Safety Update Reports (DSUR).

Comprehensive regulatory consulting and submission services for pharmaceutical and biotechnology industries covering pre-submission, submission & evaluation, and post-approval phases.

Project management service utilizing meticulously crafted plans, proactive risk management, dedicated oversight, and effective vendor management.

Comprehensive Good Pharmacovigilance Practice (GVP) solutions and services including GVP compliance, system gap analyses, PV system and process audits, merger and acquisition diligence support, and PVQA consultancy.

Wide-ranging literature screening pharmacovigilance service designed to monitor scientific literature, identify potential adverse drug reactions, and detect new safety signals.

Leveraging a global network of Key Opinion Leaders to provide critical insights on study design, patient selection, and endpoint validation.

Comprehensive biostatistics services for clinical trials delivering data integrity, validity, reliability, and interpretability through adaptive design, protocol development, statistical analysis, and CDISC conversion.

Regulatory landscape analysis and pathway planning for target markets including USFDA, EU, ROW, WHO, and DCGI.

Classical services, specialized services, and MAH system support for preparing and reviewing aggregate safety reports such as PSUR, PBRER, PADER, ASR, ACO, BRER, and J-PSUR.

Delivering patient safety, product quality, and expert communication via our medical information call center.

Support services for clinical trial initiation including Safety Management Plan, site training, and 24x7 clinical site inquiry support.

Portal management support for EU clinical trials including RPEV and CTIS Portal Management.

Support in defining study objectives, study design, sample size determination, and advanced statistical methodologies.