clinX

Compliance with regulatory requirements

Our studies were conducted in accordance with the current regulatory requirements, including IEC, NDCT 2019, and CTRI.

The well-being of patients

In all aspects of trial conduct, it is imperative to prioritize the patient's rights, safety, and overall wellbeing.

Adherence to ICH-GCP

Our studies are carried out in accordance with the quality, safety, and efficacy guidelines of ICH-GCP, while also taking a multidisciplinary approach.

providing high-quality and cost-efficient solutions

The services provided are of high quality and cost-effective due to the exceptional proficiency in utilizing available resources.

About Us

Our organization is a Clinical Research Cum Comprehensive Site Management Organization.
We have expertise in conducting clinical studies to evaluate the effectiveness and safety of completed pharmaceuticals and medical devices.

ClinX comprises a team of highly skilled professionals with over 15 years of experience in Clinical research development across various therapeutic areas.

With a deep understanding of both domestic and international ethical standards, our professionals possess a comprehensive knowledge of the Clinical Trial Industry. This expertise allows us to ensure high-quality data and adherence to study timelines at our sites.

Through our extensive experience, we have gained valuable insights into the importance of training young professionals to meet the demanding requirements of the industry.

At ClinX, we adopt a proactive management approach, enabling us to anticipate risks and establish effective communication channels with our clients.

Our dedicated Core Technical team is committed to delivering exceptional results.

Effective Communicators in terms of proposal or Query response.

We offer efficient technical support services that are delivered promptly.

Extensive range of knowledge and skills.

Services

Our organization offers comprehensive solutions for conducting clinical studies. We specialize in providing end-to-end services for clinical research and site management.

Medical writing

Clinical studies require careful preparation of protocols, ICF/ICD documents, SOPs, and CSRs. Protocol development outlines the study plan. ICF/ICD creation informs participants about the study. SOPs ensure consistent processes. CSRs compile study findings for communication. These tasks uphold research quality and ethics.

Site management

The process entails conducting a thorough study feasibility check, meticulously identifying and selecting suitable sites, diligently preparing and obtaining approval for trial-specific documents from the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), effectively recruiting subjects and ensuring their follow-up, and efficiently managing site closeout activities.

Quality assurance & auditing

Our organization provides comprehensive third-party monitoring and quality assurance audit services to ensure the integrity and quality of data at clinical study sites, while also ensuring compliance with regulatory requirements.

Data Management & statistics

We provide a rapid and adaptable solution for data entry in both paper CRF and eCRF formats. Additionally, we provide professional statistical consultation and the preparation of a Statistical Analysis Plan (SAP) to ensure efficiency and accuracy.

Regulatory services

We offer a comprehensive range of regulatory services, including protocol submission to regulatory authorities and diligent follow-up for approvals. Our expertise extends to SOP preparation, SUGAM portal registration, as well as IRB/IEC registration and re-registration.

Diploma courses & Trainning

We provide a variety of training programs in ICH-GCP, and NDCT 2019 rules, with certification. We've also created a special diploma program that combines theory and hands-on experience in clinical research, resulting in the attainment of a certificate of completion. Additionally, we offer internships in clinical research to boost students' learning and career opportunities.