Comprehensive Clinical Operations Solutions

In addition to drug safety, iPharmX supports clinical development programs with targeted operational services. We help ensure that clinical trials are conducted efficiently and in compliance with all regulatory requirements.

Our clinical operations team provides end-to-end support for clinical trial regulatory submissions and expert consulting for specialized study types. We ensure all dossiers meet regulatory requirements and comply with ICH-GCP guidelines.

We offer comprehensive support for Investigator-Initiated Trials (IITs) and Real-World Evidence (RWE) studies across APAC and global markets.

Our Clinical Operations Services

Expert clinical trial management and regulatory compliance support for efficient study conduct

Clinical Trial Regulatory Submissions

Preparation and submission of clinical trial applications and associated documents (e.g. Clinical Trial Applications, ethics committee submissions) to local health authorities and Institutional Review Boards (IRBs). We make sure all dossiers meet the regulatory requirements of each country and comply with ICH-GCP guidelines, facilitating faster approvals and study start-up.

Study Management Consulting (IITs & RWE Studies)

Expert consulting for Investigator-Initiated Trials (IITs) and Real-World Evidence (RWE) studies. Our team advises on study design, protocol development, regulatory documentation, and operational best practices to ensure these studies are well-designed and executed smoothly. We help you navigate regulatory obligations for IITs/RWE projects and optimize study conduct for reliable results.

ICH-GCP Compliance

Ensuring all clinical operations adhere to International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines. We provide guidance on implementing GCP standards throughout the clinical trial lifecycle, from protocol development to study closure.

Fast Track Approvals

Our regulatory expertise and local knowledge enable faster study start-up through efficient preparation and submission of regulatory dossiers. We understand the specific requirements of health authorities across different countries, facilitating quicker approvals.

Protocol Development

Expert guidance on clinical trial protocol development, ensuring study designs are scientifically sound, feasible, and meet regulatory requirements. We help optimize protocols for efficient execution while maintaining scientific rigor.

IRB and Ethics Committee Support

Comprehensive support for Institutional Review Board (IRB) and ethics committee submissions, including document preparation, query responses, and ongoing communication to ensure timely approvals and compliance maintenance.

Why Choose iPharmX for Clinical Operations?

Expert clinical trial management with proven track record of efficient and compliant study conduct

Regional Expertise

Deep understanding of regulatory requirements across Asia-Pacific and Beyond, enabling efficient study approvals and compliance in diverse jurisdictions.

Accelerated Timelines

Our streamlined processes and regulatory expertise enable faster study start-up through efficient preparation and submission of regulatory dossiers and documentation.

Quality Assurance

Rigorous quality management systems ensure all clinical operations meet the highest standards of ICH-GCP compliance and regulatory requirements.

Key Benefits of Our Clinical Operations Support

Ensuring efficient, compliant, and successful clinical trial execution

Faster Study Start-up

Our regulatory expertise and efficient processes enable quicker approvals and study initiation, reducing time-to-market for your clinical development programs.

Regulatory Compliance Assurance

All operations strictly adhere to ICH-GCP guidelines and local regulatory requirements, minimizing compliance risks and ensuring audit readiness.

Cost-Effective Solutions

Our targeted operational services provide access to specialized expertise without the overhead of maintaining full-time internal clinical operations teams.

Expert Study Design

Our team provides guidance on scientifically sound and feasible study designs, optimizing protocols for efficient execution while maintaining scientific rigor.

Ready to Streamline Your Clinical Operations?

Contact us to discuss how our clinical operations expertise can support your clinical development programs and ensure efficient, compliant trial conduct.

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