Clinical Lifecycle Management
Our Clinical Experts have helped our client setup successful, optimized, and compliant clinical operation
What We Do
Pre-Clinical Services
Pre-Clinical Study Design and Management: Tailored design and management of pre-clinical studies to assess safety, efficacy, and pharmacokinetics.
Toxicology Studies: Comprehensive toxicology testing services, including in vitro and in vivo studies, to evaluate the safety profile of your compounds.
Pharmacology and Pharmacokinetics: Detailed analysis and modeling of drug behavior in biological systems, providing insights into dosing and efficacy.
Biomarker Identification: Identification and validation of biomarkers for disease states or therapeutic responses.
Clinical Trial Management Excellence
Comprehensive Planning and Oversight: Expert management of all trial phases, from study design to site selection, ensuring adherence to GCP standards.
Quality Management System (QMS): Implementation of QMS-GCP with governance and operating procedures supporting development, documentation, and clinical trials.
Data Integrity and Management: Advanced technology for robust data collection, management, and analysis.
Regulatory Compliance: Expert navigation of regulatory requirements, ensuring trials meet all ethical and legal standards.
Patient Recruitment and Retention: Innovative strategies to boost patient enrollment and engagement.
Seamless IND Submission Services
Strategic Guidance: Comprehensive support in preparing and reviewing your IND application for FDA compliance.
Dossier Compilation: Assistance in compiling essential documentation, from preclinical data to trial protocols.
Regulatory Liaison: Leveraging relationships with regulatory bodies for effective communication and query resolution.
Continuous Support: Ongoing assistance from pre-IND meetings to final submission, with strategic adjustments as needed.
Additional Services
Preclinical / Clinical Development & Operations: Tailored support in the planning, execution, and management of preclinical and clinical studies.
CRO Transition and Operating Model Assessments: Guidance on CRO selection, transition processes, and assessments of operating models for optimal efficiency.
Strategic Planning & Portfolio Optimization: Development of strategic plans and optimization of your clinical trial portfolio for maximum value and impact.
Clinical Trial Design: Innovations in trial design focusing on decentralized trials, diversity, patient-centric approaches, and engagement strategies.
Technology / Platform Assessments & Recommendations: Evaluations and recommendations on the latest technologies and platforms to enhance trial efficiency and data management.
Clinical Data Management and Reporting: Comprehensive data management services, including data processing, analysis, and reporting, ensuring accuracy and compliance.
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