Clinical Research Course Pune & Mumbai

Top Clinical Research Course

Since the technological revolution, the world has emerged as a superpower with a major breakthrough in the field of healthcare and science which has increased the inquisitiveness to research and discover new findings. The amalgamation of IT, pharmaceutical, and biotech research is one such multi-disciplinary field which has given birth to infinite innovations and has been growing incessantly over the past decades. These innovations have paved paths for innumerable opportunities in the world of medicines and clinical research which have led to the constant rise in demands for jobs in clinical research fields.

Before we dig deeper into the various segments of the clinical research course, let us decode the conundrum of clinical research and how one can benefit from this course, professionally.

Clinical Research

Clinical research, yet another vertical of healthcare that focuses on trials with new drugs on patients and humans at the initial level to discover the cure for the deadly diseases. The study determines the safety, accuracy, and effectiveness of medicines and clinical devices which are tested before they are approved by the government or other regulating bodies. Clinical experts and professionals then utilize the new drugs produced to improve the health of the patients with certain sets of standards and protocols.

With the data outgrowing the population, the constant demand for clinical research and clinical data management is always on a rise. Being one of the richest designations in the world, clinical research certifications and jobs are not just worth the pay but also are liable for global recognition. This is why there is a global demand for the trained and certified clinical research professionals in the healthcare and research industry.

Best Clinical Research Course in Pune and Mumbai

Clinical Research course in Pune is curated by an adroit team of clinical research training experts who possess years of experience and expertise in the field of innovation and clinical research. TechData Solutions, one of the top clinical research course providers in Pune and Mumbai offer an exclusive platform for beginners, professionals, and students to upscale their career and widen their knowledge in the areas of clinical research. The clinical research course in Mumbai too offers an extensive training scope that includes Clinical Research Training (CTM), Pharmacovigilance(PV) training, Clinical Data Management (CDM), and Regulatory affairs.

Clinical Research Course Modules

TechData Solutions offers the best clinical research course in Pune with both technical knowledge and practical case studies. The instructor-led clinical research course in Mumbai covers the primary modules of clinical research - CDM, PV, and Regulatory Affairs with 24*7 guidance and support that fits the real-time industrial requirements. Let us walk you through the modules of clinical research and the course curriculum.

Clinical SAS Course in Mumbai and Pune

Get the best online and offline CDISC SDTM, ADaM, TLF/TLGs certified training course in Mumbai and Pune helmed by the best mentors and coaches possessing years of industrial experience and expertise.

1. Clinical Data Management (CDM)

A pivotal stage in clinical research, Clinical Data Management (CDM) focuses on analysis, collection, and integration of high-quality and reliable data at an appropriate quality and cost. The statistically sound data extracted from the clinical trials supports the code of conduct, organization, and analysis of clinical studies across the wide horizon of clinical research.

Eligibility Criteria

The program is specially developed for graduates in life science, pharma, or clinical research and IT professionals.

Course Highlights

Our adroit team of industrial experts conduct the Clinical Research course in Pune that covers all the aspects of process flows to data flows and real-time case studies with a seamless classroom and interactive experience for all students. The course is specially designed keeping the beginners in mind.

Job Opportunities and Roles - Freshers and Seniors

• Clinical Research Associate
• Clinical Research Coordinator
• Clinical Trial Assistant
• Clinical Project Manager
• Clinical Data Manager
• Research Associate
• Clinical Instructor
• Clinical Director
• Clinical Supervisor

Salary

Certified Clinical Data Managers have an annual salary in India ranging between ₹ 2.7 Lakhs - ₹ 9.3 Lakhs

2. Pharmacovigilance

Pharmacovigilance(PV) is the process through which the testing is performed to measure the safety level of a drug. Also, medicines and drugs undergo stringent testing to detect any effects before they are made available in the market. This procedure provides us valuable insights and any positive effects about the medicines created with the use of scientific innovations and methods.

Eligibility Criteria
Aspiring candidates who are graduates with a Bachelor’s or a Master’s Degree in Pharmacy, Chemistry, Science, Nursing, or Medicine. Also, it is quite essential to have the following skill sets:

• Basic knowledge of medical coding
• Effective communication
• Effective analytical and interpretive skills
• Good problem-solving skills
• Scientific writing
• Basic understanding of medical terms

Course Highlights

Whether you are a novice in the field of clinical trials and research or you have certain kind of knowledge, our Pharmacovigilance course in Pune and Mumbai is the one of a kind that will help associates and seniors from the clinical research field to focus on various aspects of medical coding, pharmacovigilance, pharmacokinetics, and case studies with real-time exercises and 24*7 guidance from certified instructors.

Job Opportunities and Roles - Freshers and Seniors

• Drug Safety Associate (DSA)
• Drug Safety Physician
• Drug Safety Specialist
• Pharmacovigilance (PV) Associate
• Medical Data Executive
• Medical coder
• Medical Writer
• PV Coordinator
• Scientific Writer

Salary

• For Freshers, the average salary for PV Associate is around 3.3 Lakhs
• In India, for Mid-level associates and seniors, the average salary ranges from ₹ ₹ 6.0 Lakhs to 8.0 Lakhs

3. Regulatory Affairs

Clinical research has various stages right from production in which regulatory affairs is one such integral part. The main purpose of this segment in the clinical trials is to safeguard the individuals. The researchers conduct the regulatory affairs by liaising between various wellbeing specialists and organizations. The RA researchers supervise the best possible way of helping the medication through the endorsement process and surveys before it advances to the market.

Eligibility Criteria

Life science or Biotech graduates with a Bachelor’s or a Master’s Degree in Pharmacy, Chemistry, Nursing, or Medicine.

Course Highlights

The pharmaceutical and healthcare industry is one of the most booming industries like never before after the pandemic crisis. This industry vertical is always in search of talented, certified, and intelligent candidates who are well-trained in the clinical research and regulatory affairs. This is why we focus on creating niche courses developed by researchers and experts who possess years of experience in the field to guide the students with what the current industry demands. Our online/offline clinical research course in Mumbai offers you basic to intermediate and advanced level courses with both basic and advanced level curriculum.

Job Opportunities and Roles - Freshers and Seniors

• Regulatory Affairs Executive
• Drug regulatory Affairs Associate
• Regulatory Affairs Consultant
• Drug safety or food safety officer
• Medical & Regulatory officer
• Quality Assurance (QA) Executive Regulatory Affairs (RA)

Salary

The salary bar varies from job profile to profile. Once you complete the clinical research course and the Regulatory Affairs course, the average package ranges between 1.8L to 4.8L annually.

Clinical Research Certification and Career Opportunities

The clinical research training and certification covers all the essential modules necessary for getting attractive career opportunities in the industry. The demand for such certified professionals is not just in the country but internationally as well with handsome salary packages. Our certification course modules cover the comprehensive processes of good clinical practice guidelines, clinical trial regulations, designs and protocols, and other methodologies involved in bringing a potential medicine or drug from the research lab to the regulatory bodies for approval and then finally the market.

With the clinical trials market size expected to reach USD 68.9 billion globally by the end of 2026, there is a huge scope for this field in the coming years which implies multiple opportunities for professionals across the globe.

Benefits of enrolling in TechData Clinical Research and Pharmacovigilance course in Pune and Mumbai

TechData Solutions has always been a pioneer in clinical research training and certifications with its branches in Mumbai and Pune. The interested students undergo training by experts and an experienced team of instructors who have years of corporate experience. They conduct training on several aspects including technical and practical knowledge, communication, analytical, and interpretive skills. We also provide unparalleled support for career guidance and interview preparation.

• Online and offline training on clinical research and modules at affordable price
• Comprehensive training with real-time projects
• Learn from Industry experts
• Weekly assignments and evaluation
• Dedicated instructor with guidance and support
• Free training and certification preparation materials
• Live Q&A sessions
• Real-time case studies
• 24*7 support
• Interview preparation and resume building

Curriculum

MODULE 1 : CLINICAL DATA MANAGMENT (CDM)

Beginner Level

• Flow of CDM - Overview
• Clinical Research Process
• Process flow for Typical Clinical Trials
• Database creation
• Clinical Trials - Drugs and Medical Devices
• Types of study and terminologies
• Protocol - Overview
• eCRF (electronic Case Report Form) - Overview
• Department and role in CRO

Advanced Level

• Drug Development Process
• Data entry
• Edit checks creation (standard check and study specific checks)
• Data discrepancies management
• Reconciliation (SAAE, AE, CONMED, etc.)
• Activities in Startup/Conduct/Closeout
• Case Studies

MODULE 2 : Medical Coding

• Human Anatomy and Physiology
• MeDRA Coding
• Case Processing
• Case Narration
• Data Summarization

MODULE 3 : Pharmacovigilance

• Schedule Y
• Trial Master File
• Data Verification
• Bioavailability
• Bioequivalence
• Pharmacodynamics
• Pharmacokinetics
• Medical dictionary for Regulatory activities(MedDRA)
• Drug discovery and development phases
• Drug safety - Overview
• Pharmacovigilance - History and Evolution. Terminologies
• Pharmacovigilance - Global guidelines
• Case Studies

MODULE 4 : REGULATORY AFFAIRS

Basic Level

• Introduction to Regulatory Affairs
  • International Regulations and Initiatives
  • CDSCO
  • FDA – Food & Drug Administration
  • ICMR Guidelines
  • Clinical Data Management
  • Good Clinical Practice (GCP)-ICH E6
  • Protocol Designing
• Introduction Medical Writing
  • Drafting a study protocol

Advance Level

• Data Archiving and Validation
• Designing and Monitoring of Trials
• Safety Reporting
• RA - Application, Approval And QA
• Privacy and Confidentiality
• Death Handling
• Medical Management of Adverse Events
• Case Studies