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FAQs
Clinical Trials FAQs
What is a clinical trial?
A clinical trial is a research study designed to evaluate the safety and effectiveness of new treatments, drugs, or medical devices in patients.
Who are the key participants in a clinical trial?
The three main groups are:
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Patients – individuals who volunteer to participate in the study.
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Investigators – doctors and researchers who conduct the trial and monitor patient safety.
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Sponsors – organizations (such as pharmaceutical companies, universities, or research institutes) that fund and oversee the trial.
What is the role of a patient in a clinical trial?
Patients participate voluntarily to receive potential new treatments and contribute to advancing medical research. They follow the study protocol and share health information with investigators.
What does an investigator do?
Investigators ensure the trial is conducted ethically and scientifically. They monitor patient health, collect data, and ensure safety throughout the study.
Who can sponsor a clinical trial?
Sponsors may include pharmaceutical companies, biotech firms, universities, government agencies, or nonprofit organizations. They provide funding and ensure the trial meets regulatory requirements.
Who are the key participants in a clinical trial (research study) ?
The three main groups are:
- Patients – individuals who volunteer to participate in the study.
- Investigators – doctors and researchers who conduct the trial and monitor patient safety.
- Sponsors – organizations (such as pharmaceutical companies, universities, research institutes or government agencies) that fund and oversee the trial.
Phases
Phases of a Clinical Trial
Pre-clinical
The pre-clinical phase involves laboratory and animal testing to evaluate the basic safety, biological activity, and potential effectiveness of a new treatment before it is tested in humans.
Phase 1
Tests a new treatment in a small group of people to evaluate its safety, determine a safe dosage range, and identify potential side effects.
Phase 2
Expands the study to a larger group to assess the treatment’s effectiveness and further evaluate its safety.
Phase 3
Involves large-scale testing to confirm effectiveness, monitor side effects, and compare the treatment to existing standard therapies.
Phase 4
Conducted after the treatment is approved, this phase tracks long-term effectiveness and monitors any rare or long-term side effects in a broader population.
Training
Capacity Building
We believe iCTS will strengthen local research capacity, fostering greater independence and leadership in clinical research among Nigerian investigators, and more.
Regulatory Compliance & Ethical Oversight
We help clinical researchers navigate complex regulatory pathways by ensuring compliance with local and global standards like NAFDAC, FDA, and ICH-GCP.
Dual Expertise
Bridging global standards with local realities.
Experience how iCTS streamlines the clinical trial process—advancing innovation with accuracy, empathy, and integrity
Site Selection & Investigator Selection
Comprehensive Trials Coordination
iCTS offers end-to-end clinical trial coordination, managing everything from protocol development to data analysis while aligning with sponsor’s goals to ensure timelines stay ontrack. With expertise in regulatory affairs, ethical oversight, and smart technology, our team delivers compliant, patient-focused trials across all phases and complexities.
Patient Recruitment & Engagement Strategies
Our team provides strategic patient recruitment services that focus on trust, community engagement, and retention.
Technology-Enabled Trial Management
At iCTS, we use technology to simplify and improve clinical trial management through digital tools that support tracking, remote monitoring, document handling, and real-time reporting, all while maintaining security and compliance.