About us

Drug safety and clinical research experts

A pharmaceutical service provider and Egypt’s market leader in safety and regulatory solutions, working with companies across Egypt, the Middle East and beyond.

Who we are

Insight Contract Research Organization is a pharmaceutical service provider that helps companies bring safe, effective medicines to patients and keep them compliant for as long as they are on the market. We are a certified CRO, registered by the Supreme Council for Clinical Research Ethics, and today we are Egypt’s market leader in safety and regulatory solutions.

Our team is made up of pharmacists, engineers and specialists who have spent their careers in drug safety, clinical research and regulatory affairs, including people who have worked inside the health authority itself. That experience on both sides of the table shapes how we work: we understand what regulators expect, and we know what it takes for a company to deliver it.

What we do

We support the pharmaceutical and biological industries across the whole life of a product. In pharmacovigilance, we run full or functional outsourced safety systems, audit existing ones, screen the scientific literature and prepare the safety documents every marketing authorization holder needs.

In clinical research, we manage local and international studies from Phase I to Phase IV, from the protocol and the approvals through monitoring, data management and analysis to the final clinical study report and publication.

In regulatory affairs, we prepare and submit registration files in CTD and eCTD format, manage products through their lifecycle, and offer regulatory consultancy to companies that need a clear strategy for Egypt, the Middle East and beyond.

We also train the people who do this work, through practical workshops and our online learning platform, Insight Academy.

Software and automation for pharma

Alongside our services, we provide software solutions and system automation customised for the pharmaceutical industry. Our products cover the safety database, online training, clinical data capture and registration dossiers, and our team helps companies move their processes and archives from paper and spreadsheets into secure electronic systems.

Vigipx, our safety database, has become the market leader in Egypt and is used by most of the country’s pharmacovigilance teams.

How we work

We believe a good partner is measured by the results a client can see. That is why we agree clear scopes, milestones and budgets at the start of every project, keep our clients informed as the work moves forward, and stay reachable whenever a question comes up.

Collaboration and integrity guide everything we do. We tell our clients what is realistic, we document our work so it stands up to any audit or inspection, and we keep our methods in line with international good practice and the latest Egyptian requirements.

Our vision

To be a global leader in pharmaceutical safety services, safeguarding public health through the highest standards of drug safety and regulatory compliance.

Our mission

To transform drug safety around the globe by bringing efficiency, reliability, flexibility and confidence to our sponsors.

Let’s discuss your next project

Share your scope, timeline and budget. We will come back with a clear plan, defined milestones and a named project lead who is accountable for delivering on time, within budget and to the quality you expect.

  • Defined scope
  • Agreed milestones
  • On time
  • Within budget
Start your project