Clinical Trial Management

Work with the latest industry tools and learn how to apply them in the domain of Clinical Trial Management.

OVERVIEW

Why Clinical Trial Management

Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. Results from trials determine whether a treatment is effective because trials incorporate features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased – a necessary element for drugs to get FDA-approved.

In This Course

Learn about the complete Regulatory activities involved in Creating Documents; and in Planning, Organizing, Monitoring, Recording, Analysis and Reporting of Clinical Trials in Human Beings. Also learn about recent advancements as well as specializations in e-Clinical Technology.

The Sollers Advantage

Our Clinical Trial Management program is taught by faculty experienced in the industry. The program includes a comprehensive 20-week academic internship where students work on a real time project using the Clinical Trial Management Software.

Learning Outcomes

  • Gain expertise in Clinical Research, Trial Design and Clinical Trial Management
  • Understand the phases of Clinical Trials, ICH/GCP guidelines and study feasibility and site selection
  • Understand the roles and responsibilities of IRB/IEC, contracts and budgets
  • Understand the essential documents prior to study start, financial disclosure form, and the clinical trial protocol
  • Understand the investigators brochure, informed consent and monitoring
  • Understand the site monitoring visits, randomization and blinding, recruitment/ retention/compliance
  • Understand the AE/SAE reporting guidelines, drug advertisement, HIPAA regulations
  • Understand the medical devices, fraud/misconduct, potential liability
  • Understand the FDA inspection
  • Understand the site closeout(on-site, remote), and site performance
  • Understand the IND/NDA application process, eCTD
  • Understand the essential documents (after study closeout), and risk based monitoring
  • Understand the evidence based medicine, personalized medicine, big data

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) Study Close Out
  • Site Close-Out Visit (On-Site/Remote activities)
  • Statistical Analysis
  • Investigational Drug Application
  • New Drug Application
  • eCTD (Common Technical Document)
  • Essential Documents (After Study Close-Out)
  • Risk-Based Monitoring
  • Evidence Based Medicine
  • Personalized Medicine
  • Big Data

INTERNSHIP

Sollers offers a 20-week internship as part of the Clinical Trial Management program that helps you gain practical experience on key concepts taught during the course. You will work on:

CTMS – Clinical Trial Management system

EDC-Electronic Data Capture Management system

eTMF-Electronic Trial Master File

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


Dr. Durdant Dave

Dean of Academics


Mark Koscin

Faculty of Clinical Research


Dr. Persis Bandari

Faculty of Clinical Trial Management


Kamal Akhtar

Faculty of Clinical Trial Management


Nisha Philipose

Faculty of Clinical Trial Management


Dr. Geetasree Alluri

Teaching Assistant for Clinical Research


Course Duration

15 weeks (20+ hours each week)

3 Sessions /week

Engagement

300 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.
  • Clinical Trials.gov reports a total of more than250,000 Trials

Yes, Internship provides an excellent opportunity for practical hands-on working experience on virtual life like functionality of various functions.