Advance PG Diploma in Clinical Research

Your First Step In The World Of Clinical Management

The clinical research industry is one of the largest and fastest-growing industries in the world. This global market funds, performs and disseminates medical research. It operates at the intersection of healthcare and business.

Clinical research is a branch of healthcare science that deals with the study of the safety and effectiveness of new medications, devices, diagnostic products, and treatment regimens intended for human use. An advance PG Diploma in clinical research offers to entail the candidate with knowledge and practically important information about the industry, working modalities, trial methodologies, drug development, post-marketing safety checks, and all other important aspects.

The Scope Of Clinical Research Today: Career prospects and job opportunities

Career prospect:

The future of clinical research is bright and limitless. A PG Diploma course in Clinical Research prepares students for careers in the healthcare field. In other words, this course provides the necessary skills and qualifications needed for the professional practice of clinical research. Students pursuing this course can make their career in the following:

What are the job opportunities after an advance PG Diploma in clinical research?

The clinical Research Industry has grown worldwide at a remarkable pace in recent years. Therefore, once the students complete the course, they get several opportunities. Some such jobs are discussed below:

A clinical trial associate is a health care professional who works on the clinical trial team for a pharmaceutical company. The clinical trial associates perform administrative and clinical research/clinical trials tasks.

The Clinical Research Coordinator is the individual who oversees the research process for a clinical trial. The coordinator works closely with patients and medical staff to ensure timely study participants and all tests. The clinical research procedures and treatments are carried out in accordance with the study's protocol. The clinical research coordinator is responsible for the following tasks:

  • Matching research subjects with clinical trials.
  • Conducting pre-trial interviews and medical examinations of trial subjects.
  • Maintaining patient records, including patient consent forms.
  • Ensuring that all trial procedures are followed.

A senior clinical research associate has experience and knowledge in the field. Therefore, they provide the necessary expertise and guidance in clinical research. The role of the Senior Clinical Research Associate (SCRA) is to lead a team of research associates in conducting clinical trials. The SCRA is responsible for managing the clinical trial process and overseeing daily operations, including the study protocols, clinical trial budgets, and timelines.

The position is both a management and administrative role as they are required to manage the day-to-day operations of the clinical trials team clinical trials and oversee the planning of research.

 

Also Read : How to become a Clinical Research Associate?

A medical coder is a person who enters and codes medical billing data into an electronic form for a health care provider.

The role of a medical coder is to make sure the medical record is in order and complete. This can require gathering data from other sources, coding information into a format that makes sense, and creating the final file.

A medical writer is a professional who writes health-related texts. Often, they are the person that conveys scientific information to patients and doctors by translating research findings into language accessible to all.

Medical writers are responsible for the accuracy and completeness of medical documents, including patient consent forms, medication information sheets, brochures, and more. Medical writers are responsible for creating text, images, and video content that is not only understandable but also compelling.

The role of a clinical trial writer is to design, write and edit the technical content for a clinical trial. This includes formulating study protocols and procedures, such as writing scientific manuscripts and therapies. Clinical trial writers can also help individuals or organizations conduct research studies on the effectiveness of medical treatments and interventions. They are responsible for managing the scientific team and timelines; writing the patient information booklet, consent forms, and other related clinical trial documents.

Features of our advance PG Diploma in clinical research: What do you get?

Topics Covered Under This Diploma Program

The entire course of advance PG Diploma in clinical research covers all the important and necessary modules, some of which are discussed below:

A clinical trial is a research study in which one or more experimental therapies, nutraceuticals, and other types of interventions are tested for safety and effectiveness. In other words, clinical trials can be designed to test pharmaceuticals, medical devices, procedures, diagnostic tests. The duties of a clinical research associate during clinical trial operations typically include planning, organizing, conducting, and analyzing laboratory experiments for study subjects to provide them with the most effective treatment.

Clinical data management is the study of collecting, analyzing, and reporting clinical trial data. This clinical research course can be broken down into three categories: preclinical, clinical trials, and epidemiologic studies. The study of clinical data management is necessary to ensure the safety of participants and adherence to ethical principles.

 

Also Read : Clinical Data Management- Everything you need to know about the course

Pharmacovigilance is the process of monitoring drug safety and protecting human health during clinical trials. It involves gathering, analyzing, and disseminating information about adverse events that occur during a trial in surveillance after the marketing authorization has expired. The study of this course is important because it enables the student to identify factors that may have led to the adverse events, and take appropriate corrective actions. Under this study, the pharmacist undertakes the responsibility of ensuring that drugs do not harm patients in clinical trials.

Medical writing is a type of professional communication that focuses on the accurate and persuasive documentation of medical information. It includes the production and dissemination of health-related materials such as papers, books, conferences, and workshops. In addition, medical writing is concerned with what a patient might want to know about their condition or care. PG diploma clinical research covers the following topics:

  • Patient safety and quality of care
  • Patient communication
  • Evidence-based medicine
  • Accurate and unbiased data study

Soft skills are the non-technical skills that complement a person's technical skill set, such as communication and leadership. Clinical research professionals should have a strong understanding of the profession and its norms to be effective in their work. The soft skills for a clinical research professional include creativity, empathy, and as already stated, leadership, and communication.

Methodology, Program Structure, Focus, and Faculty

Methodology

The students will be taught the courses via lectures, assignments, group discussions, workshops, case studies, and site visits conducted by professionals of various industries. We encourage hands-on learning and incorporate advanced tools to boost their confidence and ensure a successful career.

Program Structure

Over the course of 4 months, students will be taught 26 interesting topics. The program is divided into basic and advanced modules as tabulated below:

BASIC MODULES
ADVANCED MODULES
Fundamentals of Clinical Research
Laboratories and Interactive Response Systems
Phases of Drug Development
Patient Safety and Pharmacovigilance
History of Clinical Trial Conduct
Monitoring Clinical Trials
Setting up a Clinical Trial
Audits and Inspections by Regulatory Authorities
The interplay between Contract Research Organizations and Site Management Organizations
Patient Recruitment, Handling and Retention
Regulations of Clinical Trials on a global and local scale
Standard Operating Procedures in Clinical Trials
Understanding a study protocol
Maintaining Data Quality and Accuracy
Responsibilities of the principal investigator and sponsor
Medical Writing and Publication
Ethics in clinical trials
Biostatistics
Obtaining informed consent from patients
Patents in Clinical Research
Investigational Product Management
Data Analysis and Management
Documenting Observations and Results
Soft Skills Training
Safeguarding Essential Documentation
IT Skills Training

Focus

The course is divided into four sections, each with a different focus:

1.The first section focuses on the legal aspects of clinical research, which includes discussions about informed consent and confidentiality violations.

2.The second section focuses on the scientific research process and includes experimental design and power analysis discussions.

3.The third section focuses on ethics in clinical research, including discussions about the different ethical frameworks in bioethics.

4.The fourth section focuses on clinical data management, which includes discussions about how to handle data and metadata in practice.

Faculty

Our faculty consists of renowned professionals with 5-10 years of experience in the clinical research industry, presently working in senior positions in contract research organizations or multinational pharmaceutical companies.

Internship

Many of the topics you will study are directly applicable to the practice of clinical research, meaning that you will be able to utilize the skills taught in lectures and put them into action immediately. For example, if you are taught about the need to obtain consent from a patient in order to enroll them into a clinical trial, you will also have the opportunity to carry out this procedure yourself. Through this hands-on course, you will also gain and polish essential skills to thrive in any workplace such as fantastic communication, organization, and time-management skills.

Assessments

Over the duration of the course, candidates will be required to go through weekly assessments. This will help them for self evaluation. After complyou will be assessed twice in the form of written examinations. The first exam will test your understanding of the initial 13 topics and the second will test your understanding of the next 13.

Fees and Scholarships

The fees for a 6 month-long advanced diploma course in clinical research is Rs. 65,000/- for all students who wish to begin a flourishing career in this sector.

As Lifepoint Research is committed to providing equal opportunities for all, we offer a number of needs-based scholarships towards course fees for students from economically disadvantaged backgrounds

  • Program-specific lectures and tutorials from well-qualified and well-trained faculty members
  • A 3 month-long internship that offers invaluable practical knowledge related to the sector
  • Access to the institute’s computers and internet facilities
  • Guest lectures from renowned and experienced professionals working in the industry

We accept payments in several forms including cash, cheques, and wire transfers.

Candidates who are eligible for our advance PG Diploma in clinical research must come from one of the following streams:

  • MBBS/BDS/BAMS/BHMS
  • Pharma Candidates
  • M.Sc./B.Sc
  • Paramedical Science graduates
  • Physiotherapists
  • Biotechnology and microbiology candidates
  • Candidates with work experience in the health/pharmaceutical sector
  • Candidates engaged in clinical research and related operations

The Admission Procedure For Our Advance PG Diploma In Clinical Research

Step 1: Online Application

The first step for the PG Diploma in clinical research course admission procedure is sending an online application. To do this:
1.Log in to the online application portal with your email ID and password.
2.Fill in all the details and upload your resume (CV).
3.Ensure that you have read the PG Diploma in clinical research course terms and conditions carefully before submitting your application.
4.Register for the PG Diploma in clinical research course by submitting your application and fee payment online.

Step 2: Screening Round and Counselling

The second step for the admission procedure for the PG Diploma in clinical research course consists of two rounds: screening round and application.
The screening round is the first round conducted to select the eligible students. In this round, candidates must submit a completed application form and a set of documents.
The next step is the selection round, where candidates are selected based on their application and submitted scores. The final step is admission to the advance PG Diploma in clinical research.

Why choose Lifepoint Research for an advance PG Diploma in clinical research?

Lifepoint Research is a leading provider of advance PG Diploma in clinical research. We aspire to create skilled manpower that is industrially ready for clinical research.At Lifepoint Research, we have highly educated and experienced faculty who are renowned for providing wonderful and interactive classes along with 100% placement aid. Our curriculum and internships are specially designed by industry experts for students’ sustainance and growth in the industry. Not only that, but we have also restricted our batch strength to be able to give better attention to every individual. With the backing of apt and up-to-date information and training required, we help our students become skillful and confident. For more than six years, we have been delivering excellence and innovation to our students with our learning platform, which has proven to be a success. Our ingenious approach has been recognized widely, and the testimonies of our students demonstrate our distinction and quality support. For more information, contact us today!