We provide an end-to-end (full-service) clinical research consulting services that manage the entire clinical development process, from preclinical research through to post-marketing surveillance. This integrated approach streamlines the development of new drugs, medical devices, and therapies for the sponsor company.

 

Key services offered by end-to-end CROs include:

Early Stage & Preclinical Services -

Discovery Support: Target identification, lead optimization, and early-stage laboratory assays.

Preclinical Research: In vitro and in vivo testing (pharmacology, toxicology, pharmacokinetics, pharmacodynamics) to evaluate the safety and efficacy of potential treatments before human trials.

 

Clinical Trial Management (Phase I-IV) -

Protocol Design & Development: Collaborating on a comprehensive and scientifically sound research plan.

Project Management: Overall coordination, timeline management, and resource allocation for the entire trial lifecycle.

Regulatory Affairs: Advising on regulatory pathways, preparing and submitting necessary documentation (IND, NDA, etc.) to health authorities (e.g., FDA, EMA), and ensuring ongoing compliance with Good Clinical Practice (GCP) and other standards.

Site Selection & Management: Identifying, evaluating, initiating, and managing suitable investigational sites and investigators.

Patient Recruitment & Retention: Developing and implementing strategies to identify, enroll, and maintain a diverse and sufficient patient population.

Clinical Monitoring: Conducting routine site visits to monitor trial progress, verify data accuracy, ensure protocol adherence, and protect patient safety and well-being.

Laboratory Services: Providing central and bioanalytical laboratory services, including biomarker analysis and specialty testing.

 

Data Management & Analysis -

Data Management: Designing databases, managing data collection (often using Electronic Data Capture (EDC) systems), ensuring data accuracy and integrity, and performing quality control.

Biostatistics & Statistical Analysis: Developing statistical analysis plans, performing in-depth data analysis, and generating insights for decision-making.

Medical Writing: Preparing study protocols, informed consent forms, clinical study reports (CSRs), and manuscripts for publication.

 

Safety & Post-Market Activities -

Pharmacovigilance: Ongoing monitoring, detection, assessment, and reporting of adverse events and drug safety issues throughout the product lifecycle.

Quality Assurance (QA): Implementing rigorous quality management systems and conducting audits to ensure all activities meet the highest standards.

Post-Marketing Surveillance: Phase IV studies and real-world evidence (RWE) generation to monitor long-term safety and effectiveness of approved treatments.