Our Services

Clinical Data Management

Clinical Data Management (CDM) is a crucial component of clinical research and drug development. It involves the collection, organization, validation, and secure storage of clinical trial data generated during the testing of new medical treatments or drugs. CDM ensures that the data collected from patients and study sites are accurate, complete, and compliant with regulatory standards.

CDM helps streamline the drug development process by providing high-quality, error-free data to researchers, sponsors, and regulatory authorities. Accurate and well-organized data allow for efficient analysis, faster decision-making, and ultimately, the timely introduction of safe and effective drugs to the market. In this role, we specialize in offering end-to-end CDM services, including electronic data capture, data management planning, database design, data validation, and more.

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OUR CTM Process

CTM Process

Project Initiation and Planning : Collaboratively define project goals, create a detailed plan, and establish communication and roles within the team.

Data Capture and Entry : Use Electronic Data Capture (EDC) or paper-based methods to gather accurate data from global clinical sites.

Database Design and Build : Develop a compliant and real-time database structure with validation rules.

Data Validation and Cleaning : Implement checks and resolve discrepancies, ensuring data quality.

Medical Coding : Standardize medical term coding and adverse event reporting. CDASH Compliant Deliverables: Generate industry-standard, structured datasets for easy analysis.

Real-time Data Access and Reporting : Provide timely data access, custom reports, and dashboards.

Regulatory Compliance : Comply with global and local regulations, and prepare regulatory submission documents.

OUR services

Clinical Trial Management

CDM
Medical Writing
Regulatory & Clinical
Data CRO
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    Clinical Data Management (CDM)

    Clinical Data Management is pivotal in drug development, ensuring accuracy and safety. We handle Electronic Data Capture (EDC), Data Management Plans (DMPs), CRF/eCRF design, data validation, query management, medical coding, safety data, and CDASH compliance. Our CDM services expedite decision-making, enhance patient safety, and streamline drug development.

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    Medical Writing

    Medical Writing is vital for clinical research documentation and regulatory compliance. Our services include Clinical Study Reports (CSRs), study protocols, CTD preparation, investigator brochures, safety narratives, patient information, and pharmacovigilance documents. We ensure transparency and regulatory compliance, fostering deep understanding through CSRs, protocols, CTD sections, and investigator brochures.

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    Regulatory and Clinical Writing

    Regulatory and Clinical Writing aligns with global regulations and communicates trial results effectively. Our services cover ICH GCP-compliant CSRs, CTD preparation, investigator brochures, patient safety documents, and SOPs. We ensure regulatory compliance and transparency with CSRs and CTD sections. Our investigator brochures and SOPs maintain quality and adherence to industry standards.

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    Data Management CRO

    As a Data Management CRO, we ensure high-quality data collection and management in clinical trials. Our services encompass clinical data capture, EDC, DMPs, query management, external data, database locking, and data quality monitoring. We guarantee data readiness for analysis, tailored EDC solutions, comprehensive data management with DMPs, and efficient query resolution.

Why Choose Us CTM Expertise

CTM Expertise

Experienced Team : Our clinical data management experts and medical writers have extensive experience in pharmaceuticals and healthcare, ensuring your projects are in capable hands.

Global Reach : With a global presence, we adapt our services to meet clients' unique needs and navigate diverse regulatory landscapes seamlessly.

Industry Certifications : We hold ISO standards and CDISC compliance certifications, reflecting our commitment to quality and data integrity.

Tailored Solutions : We customize our approach to your specific requirements, collaborating closely to align with your partnership objectives.

Quality Commitment : Rigorous quality control standards underpin our services, resulting in accurate documentation and error-free data, prioritizing patient safety.

Ethical and Scientific Standards : Our medical writers adhere to the highest ethical and scientific standards in document preparation, ensuring accurate and ethical presentation of research findings.

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