India is noted for its diversity, both in terms of people and medical concerns. India has emerged as a global powerhouse for clinical research due to its rapid growth and innovative culture. Overall, these facts clearly demonstrate India’s major role in the worldwide clinical research scenario. India is undoubtedly a unique contributor and pioneer in determining the future of the clinical research business. The statistics provided below will help you better comprehend India’s flourishing clinical research business. The clinical research future in the Indian sector is predicted to reach USD 3.15 billion by 2023, with a CAGR of roughly 12.4% throughout the projection period.
Importance of Clinical Operations
Clinical operations are an important aspect of the healthcare business since they ensure the effectiveness of the services provided by healthcare organizations. The operations department works to ensure that all healthcare professionals and patients have what they need to collaborate effectively and that the process runs smoothly. These teams can be very useful during the medication development process. After discovery and preclinical studies are finished, the clinical development phase begins. This stage includes clinical trials and volunteer studies to ensure that the medicine is safe for human usage. Cline’s play an important part in ensuring the success of these trials. Clinical operations are distinct from clinical development. Read a customer case study about “clinical trial design “to gain further insight into the differences between clinical operations and clinical development.
Why choose Clinical Research Operations
One can have a very fulfilling job by working in clinical research. In the forefront of creating novel cures and treatments will be you, as a clinical researcher. Everything from planning and developing studies to gathering and evaluating data will be your responsibility throughout the entire research process. It’s a demanding job, but one that pays very well. Experts in the field will mentor you as well in order to help you advance and succeed in your profession. Apart from acquiring knowledge from top-notch instructors, you will also form wonderful relationships with your peers, who are highly encouraging of each other.
Career Growth Clinical Operations
Clinical Operations coordinator careers have grown by 14.09 percent countrywide during that period, with a median growth rate of 2.35 percent annually. Depending on his expertise and skills, a clinical research associate can hold a variety of positions within an organization. Employees who lack experience or are new to the company may begin as clinical research administrators before transitioning to CRA positions. A CRA can operate at many levels, ranging from Level I to Level III, or Senior CRA. The degree of employment affects the duties and responsibilities. Setting up trials, gathering data, compiling material, etc. is assisted by Level I CRAs. Senior CRAs are more active in coaching, training junior staff, devising trial protocols, and project managing across many sites.
CURRICULUM
Introduction to Clinical Operations
- Role of Clinical Operations
- Clinical Trial Phases
- Regulatory Framework
- Key Stakeholders
- Clinical Operations Team
Study Planning and Initiation
- Feasibility Studies
- Budgeting and Resource Allocation
- Site Selection and Activation
- Investigator Meeting Coordination
- Regulatory Document Preparation
Clinical Trial Management
- Project Management
- Site Management
- Monitoring and Quality Control
- Risk Management
- Data Management Coordination
Study Close-Out and Reporting
- Study Close-Out Procedures
- Data Cleaning and Lock
- Final Report Preparation
- Regulatory Submissions and Inspections
- Post-Trial Activities
