Advanced Clinical Research

Learn to conduct clinical research, collaborate with clinical scientists and enhance your skills in patient-oriented research.

Overview

Why Clinical Research

Learn about the Clinical Trial Management process, the development of complete Regulatory activities in Creating Documents, and Reporting of Clinical Trials in Human Beings. Also learn about recent advancements as well as specializations in e-Clinical Technology.

In This Course

Study Startup: Understand the phases of the Clinical Trial, ICH-GCP guidelines, Study Feasibility and Site Selection. Study Conduct: Learn about Site Monitoring Visits which include Remote and Central Risk-Based Monitoring. Study Closeout: Learn about Site Close Out Visit including both On-Site and Remote activities.

The Sollers Advantage

Get hands-on training in Clinical Trial Management System,Electronic Data Capture Management System, and Electronic Trial Master File Management System. Work on real time Case Scenarios, Clinical Tasks and other Site Management activities taught by industry experts.

Learning Outcomes

  • Learn about the IRB/IEC.
  • Clinical Trial Budgets and Contracts.
  • Essential documents maintained by the Trial Site and Sponsor.
  • Financial Disclosure Form.
  • Recruitment, Retention and Compliance of patients in the Trials.
  • Adverse Event and Serious Adverse Event reporting guidelines.
  • Drug Advertisement.
  • Investigational New Drug.
  • Application process.
  • Electronic common technical document

Syllabus

  • Phases of the Clinical Trial
  • ICH-GCP Guidelines
  • Study Feasibility/Site Selection
  • IRB/IEC
  • Budgets
  • Contracts
  • Essential Documents (Prior to Study Start)
  • Financial Disclosure Form
  • Clinical Trial Protocol
  • Investigator Brochure
  • Informed Consent Process
  • Monitoring- General introduction to all the types of visits Study Conduct
  • Site Monitoring Visits (Include Remote/Central Risk-Based Monitoring Concept)
  • Randomization/Blinding
  • Recruitment/Retention/Compliance
  • Adverse Events/Serious Adverse Events
  • Drug Advertisement
  • HIPAA Regulations
  • Medical Devices
  • Fraud/Misconduct/Potential Liability
  • FDA Inspection
  • Essential Documents (During Study Conduct)
  • Site Close-Out Visit (On-Site/Remote activities)
  •  Statistical Analysis
  • Investigational Drug Application
  • New Drug Application
  • eCTD (Common Technical Document)
  • Essential Documents
  • Risk-Based Monitoring
  • Evidence-Based Medicine
  • Personalized Medicine
  • Big Data

INSTRUCTORS

Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.

Padma Iyer

Faculty of Clinical Research


Mark Koscin

Faculty of Clinical Research


Course Duration

15 weeks (20+ hours each week)

3 Sessions /week

Engagement

150 hours

For information regarding fee and/or reserving your spot, contact our Admissions Team.

OUR STUDENTS WORK AT

Sollers partners with industry-leading corporations and provides them with ready-on-day-one employees. We record an 82% placement rate within three months of graduation.

Financial Options

Sollers has devised viable financial options for you to ensure tuition does not get in the way of your education. Now, you can focus your attention where it needs to be – in the classroom!

Career Guidance

After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.

Student Testimonials

  • Emmanet T.
    The Clinical Trial Management course is extensive, and the professors are thorough in delivering the course materials using real life experience and insight. Career Services helped me throughout the interview process, and I landed my dream job with the very first interview after graduating from Sollers.
    Emmanet T.
  • Rudolf M.
    Thanks to the academic team at Sollers, I was able to gain quick admission with financial options to pay tuition. Career Services was very helpful with resume and interview prep. They sent me job postings with major hospitals and pharma companies which helped me land my current job as Data Manager in cancer clinical trials.
    Rudolf M.

Campus Visit

FAQs

This is a 300 Hour program

Graduates from science, nursing, pharmacy, medical, dental, and computer background can take this program

Basic knowledge to work with Computers, quick learning aptitude to get trained in newer software application tools, company SOP, Medical terminology, Clinical SAS, willing and ready to travel.

Understanding of ICH/GCP clinical trial paradigm, Roles and responsibilities of various functionaries of Clinical trial process.

Detailed training of Clinical Trial Manager, Monitor, Coordinator, Data analyst functions

Be proficient to work on EDC based Risk Based Monitoring along with user friendly knowledge of relevant tools like CTMS, eTMF, Clinical SAS.

Excellent and versatile senior faculty from Clinical trial industry.

Clinical Trials are ever expanding area for drug development process.

More than 20,000 Trials were added during 2016 with annual increments of at least 6% per annum.

ClinicalTrials.gov reports a total of more than 250,000 Trials

Industry Facts

Clinical Research has proven to be exceedingly more necessary by health organizations and pharmaceutical companies in today’s modern age. This trend can be summarized by two realities: higher rates of chronic diseases and a fast-growing global population. These two elements combined, create a need for the technological advancement throughout the industry; methods and techniques that can be developed quickly to help treat the growing medical issues of today and of the future (Yau, Promising Futures for Scientific and Clinical Research Professionals, 2014).

Clinical Research has just been ranked as one of the hottest jobs with the 2nd highest salary in the life sciences sector in a BioSpace news article today. (READ MORE)

The highest paying life sciences jobs.

Importance of clinical trials. (READ MORE)

Growing demand for clinical trial studies justifying the demand for qualified clinical trial professionals.