clinical research

About Us

With over 20 years of experience in clinical research, our founder leads our team in providing top-notch clinical trial support to the healthcare industry. Specializing in Clinical Operations, Project Management, Clinical Data Management, Medical Writing, Quality Assurance and Regulatory Affairs and Biostatistics, we are dedicated to delivering the latest technology-driven solutions.

Our Services

Innovative Solutions Offered

We provide a comprehensive range of clinical research services to support accurate clinical trial support to Pharmaceutical/Biotechnology, Medical Device industry, Research Institutes and Investigators.

Our state-of-the-art facilities and expert staff ensure reliable results for your healthcare needs.

Clinical Operations

Overview

At Clinomatrix, our Clinical Operations team is dedicated to advancing the future of healthcare by managing and executing high-quality clinical trials. We combine industry-leading expertise, innovative technologies, and a deep commitment to patient safety to support the development of life-changing therapies.

Our comprehensive clinical trial solutions cover the entire lifecycle of research from initial study design to regulatory submission and post-market surveillance.

We are committed to delivering exceptional clinical trial services across all phases of development, while maintaining the highest standards of compliance, integrity, and ethical practices.

Clinical Trial and Project Management

We manage all aspects of clinical trials, including:

Study Design & Protocol Development: Tailored clinical protocols designed to meet regulatory requirements and scientific objectives.
Site Selection & Monitoring: Identifying and managing qualified clinical trial sites, ensuring adherence to GCP (Good Clinical Practice).
Patient Recruitment & Retention: Implementing strategies to recruit diverse patient populations and maintaining high retention rates throughout the trial.

what-are-regulatory-affairs-in-the-pharmaceutical-industry.jpg

Quality Assurance and Regulatory Affairs

Navigating the complex regulatory environment, we support IND (Investigational New Drug) submissions, CTA (Clinical Trial Application) filings, and regulatory submissions for all phases of clinical development. We ensure compliance with:

FDA, EMA, and other global regulatory bodies.
Protocol amendments, adverse event reporting, and post-marketing surveillance.

Data Management & Biostatistics

Our team ensures robust and reliable data collection and analysis through:

Electronic Data Capture (EDC) systems for real-time data collection and monitoring.
Statistical Analysis and interpretation of data for accurate, actionable insights.
Data Quality Assurance to ensure integrity, completeness, and consistency.

Our Approach

We take a systematic, data-driven approach to clinical trial management, leveraging cutting-edge technology and proven methodologies to ensure successful outcomes:

The Clinical Trial LifecyclePlanning & Design: We begin with a thorough understanding of the scientific and regulatory requirements to create a tailored study protocol.

Execution & Monitoring: We oversee every aspect of the trial’s execution, providing comprehensive monitoring and data collection to ensure regulatory compliance.

Analysis & Reporting: After data collection, we use advanced statistical analysis to interpret results and generate detailed, actionable reports.

Regulatory Submissions & Post-Market Surveillance: We support our clients through the regulatory submission process and provide post-market surveillance services to ensure long-term safety and efficacy.

Commitment to Quality

Our clinical operations are built on a foundation of quality:

Adherence to GCP (Good Clinical Practice), ICH (International Council for Harmonisation) guidelines and other Regulatory requirements.
Continuous quality assurance processes to ensure trial integrity and patient safety.
Regular audits and inspections to confirm regulatory compliance and identify areas for improvement.

Technological capabilities at Clinomatrix

we use state-of-the-art technologies to streamline clinical operations:

Clinical Trial Management Systems (CTMS) for project tracking and management.
IWRS
Electronic Data Capture (EDC) systems for real-time data collection and access.
Remote Monitoring & Telemedicine tools to improve patient engagement and reduce site visits.
Risk-Based Monitoring (RBM) tools to prioritize clinical site oversight and reduce unnecessary costs.

Global Reach

We have experience managing clinical trials in over 15 countries, working with a diverse network of clinical sites worldwide. Our international expertise ensures that we can navigate the regulatory landscapes of multiple regions, offering seamless support for global studies. Multilingual staff to facilitate communication with global clinical sites.

Proven capability in handling multinational studies that involve complex logistics and diverse populations.

Compliance & Ethics

At Clinomatrix, we hold patient safety and ethical standards in the highest regard. We ensure that all clinical trials are conducted in full compliance with:

Good Clinical Practice (GCP)
International Council for Harmonisation (ICH) Guidelines FDA and EMA Regulations.
Patient consent, confidentiality, and safety are integral to every study we conduct, ensuring that our research benefits the community while safeguarding participants' rights.

Why Choose Us?

Expert Team - Our clinical operations team is comprised of experienced professionals with deep expertise across multiple therapeutic areas, including oncology, cardiology, neurology, and rare diseases.
Key members includes Clinical Project Managers (CPMs) Clinical Research Associates (CRAs) Biostatisticians and Data Analysts, Regulatory Affairs Specialists.
Each member is trained in the latest regulatory standards, ensuring the highest level of expertise at every stage of the clinical trial process.
Proven Track Record With over 20+ successful trials conducted, we have a proven track record of accelerating drug development while ensuring patient safety and regulatory compliance.
Our innovative approaches and commitment to quality have led to the successful approval of numerous therapies in both local and international markets.