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Ensuring Ethical Standards in Clinical Research

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Quality Work Through Dedication

The Central Independent Ethics Committee (CIEC) is committed to upholding the highest ethical standards in clinical research to safeguard the rights, safety, and well-being of human subjects.

Multidisciplinary Expertise

Our committee comprises medical professionals, scientists, legal experts, and non-medical members, bringing a comprehensive approach to the ethical review of clinical trials. This diversity ensures a well-rounded and impartial evaluation of all protocols.

Commitment to Transparency and Integrity

Fostering Innovation through Ethical Oversight

Responsive and Supportive

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Comprehensive Ethical Review

We conduct a thorough review of clinical trial protocols to ensure compliance with ethical guidelines and regulatory standards. Our aim is to protect participants’ rights and ensure that trials are scientifically sound and ethically justified.

Confidentiality and Data Privacy Safeguards

Ensuring participant confidentiality is one of our top priorities. We assess the measures put in place to protect sensitive data and maintain the privacy of all clinical trial subjects, aligning with national and international privacy regulations.

Ethical Advisory and Consultation

Our committee offers expert advisory services to research institutions, pharmaceutical companies, and hospitals on best practices in ethical compliance. Whether it’s navigating complex ethical dilemmas or addressing legal concerns, CIEC provides comprehensive support.

Multidisciplinary Expertise

An Ethics Committee should be composed of a diverse group of professionals, including medical experts, scientists, legal advisors, and non-medical members. This ensures that the review process is well-rounded, considering various perspectives from both scientific and ethical standpoints. A balanced composition promotes unbiased decision-making.

Rigorous Ethical Review

The committee’s primary function is to rigorously review clinical trial protocols to ensure compliance with ethical standards and regulatory requirements. This includes assessing risks, evaluating the scientific merit of the research, and ensuring that the rights and safety of participants are prioritized throughout the study.

Protection of Participant Rights

A critical function of an Ethics Committee is to safeguard the rights, dignity, and welfare of participants. This includes ensuring that participants are fully informed about the trial’s risks and benefits, consent is obtained freely, and their privacy and confidentiality are maintained.

Ongoing Oversight and Monitoring

The Ethics Committee should provide continuous oversight of approved clinical trials. This includes monitoring compliance with the approved protocol, reviewing any amendments, and assessing serious adverse events (SAEs). Regular monitoring ensures that any ethical issues arising during the study are promptly addressed.

Commitment to Transparency and Accountability

Transparency in the committee’s decisions and processes builds trust among researchers, participants, and regulatory bodies. An Ethics Committee should provide clear communication about its reviews, decisions, and any conditions for approval, fostering accountability in clinical research.

Compliance with Regulatory Guidelines

An Ethics Committee must operate within the framework of national and international regulations, such as those set by the Central Drugs Standard Control Organization (CDSCO) and Schedule Y in India. Ensuring adherence to these legal requirements guarantees that clinical trials are conducted responsibly and in accordance with ethical norms.

Why Choose Us

We are dedicated to creating an environment where medical advancements are achieved ethically and responsibly, with the well-being of participants at the heart of every decision.

Uncompromising Ethical Standards

Our rigorous review process guarantees compliance with national & international guidelines, providing peace of mind to sponsors, researchers, & trial participants.

Personalized Support and Guidance

From protocol submission to approval, our team offers clear, actionable guidance to navigate ethical and regulatory challenges efficiently.

Timely and Efficient Reviews

We offer prompt & efficient ethical reviews, helping to keep your trials on schedule while ensuring full compliance with ethical standards.

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Reach Us

Location:

Gini Aria, A-703, S. No. 16/2/2A/1, Opposite to KJEI’s Trinity College, Kondhwa Annex, Pune, Maharashtra – 411048, India

Email:

info@centraliec.com

Phone:

+91 99751 67908

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