Clinical Research Courses

At Qtech-Sol, we specialize in Clinical Science Training, and our advanced program is meticulously designed for individuals who aspire to excel as Advanced Clinical Research Associates (CRAs) and take on pivotal roles in clinical trial management. Our program goes beyond the fundamentals, focusing on equipping students with the specialized skills and knowledge required for this elevated responsibility.

Qtech-Sol specializes in Clinical Science Training, offering a comprehensive program geared towards individuals aspiring to work as Clinical Research Associates (CRAs) or Clinical Research Coordinators (CRCs). Our course is meticulously structured to provide a strong foundation and practical skills necessary to meet job roles.

The CTPH program introduces learners to Clinical trials progress through Phases I–IV, each addressing unique objectives in drug development — from first-in-human testing to post-marketing surveillance. Effective Clinical Trial Management (CTM) ensures that these phases are executed efficiently, ethically, and in compliance with regulatory standards such as ICH-GCP, FDA, and EMA the structure, conduct, and management of clinical trial phases

The Trial Master File (TMF) is the cornerstone of regulatory compliance in clinical research. As outlined in ICH-GCP E6(R2), essential documents must be collected, maintained, and archived to demonstrate trial integrity, subject protection, and data reliability.

The informed consent process (ICP) is the cornerstone of ethical clinical research, ensuring that trial participants fully understand the study, its risks, benefits, and their rights before agreeing to participate. Regulatory bodies such as the FDA, EMA, and ICH-GCP mandate strict standards to protect participants’ safety, rights, and well-being.

Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects. Developed by the International Council for Harmonisation (ICH), GCP ensures that trial participants’ rights, safety, and well-being are protected, and that data generated is credible and accurate.

Clinical Trial Management requires collaboration across sponsors, CROs, and clinical sites. Within this ecosystem, roles such as Clinical Research Associate (CRA), Clinical Trial Assistant (CTA), Clinical Research Coordinator (CRC), and Clinical Study Manager (CSM) are vital for ensuring trial efficiency, regulatory compliance, and patient safety.

Site management is one of the most critical functions in clinical trial execution. From initiating a site, ensuring ongoing monitoring, and performing a final closeout, every step requires adherence to ICH-GCP standards, regulatory guidelines, and trial protocols.

Clinical Trial Management Systems (CTMS) are the backbone of global clinical operations, enabling sponsors, CROs, and sites to track milestones, manage sites, monitor resources, and ensure regulatory compliance.

Medidata RAVE EDC is the industry’s leading platform for capturing, managing, and reporting clinical trial data. It supports global studies across multiple therapeutic areas by streamlining eCRF design, data entry, query management, and integration with CTMS, eTMF, and Safety systems.

Veeva Vault Clinical Suite is one of the most widely used cloud platforms for managing clinical trial operations. It unifies Trial Master File (TMF), Clinical Trial Management (CTMS), and Study Startup (SSU) into a single system, enabling faster study execution, streamlined compliance, and perpetual inspection readiness.