SlideShare a Scribd company logo
Clinical Research Course by
ProRelix Lifesciences
www.prorelix.com
| Lifesciences Pvt. Ltd.
“ProRelix offer several professional, educational and informative services and
resources for drug development and analysis on the industry to support clinical
research. We specialize in a wide range of tools and resources to aid patient
and investigator recruitment, remain current with industry trends and business
practices, and strengthen organizational procedures. Our strong database and
a fine assortment of industry resources make us an adept organization. In a
highly fragmented industry, we are one of a group of organizations with the
capability and expertise to conduct clinical research, on either a local or global
scale. We have the operational flexibility to provide drug development services
on a stand-alone basis or as part of an integrated full service solution.”
“In a highly fragmented industry, we are one of a group of organizations with
the capability and expertise to provide drug development services.”
Relix | Lifesciences Pvt.
Ltd.
Mission
To provide world class services to improve the quality of health care and
reduce the efforts of our client in order to accelerate the overall process of
drug development. We provide customized and effective solutions as per
the needs and objectives of each task, all while complying with the highest
international quality standards and practices.
Vision
As we move towards our goal of becoming a world class organization, our
vision is to scale the great heights of innovation and outstanding services in
order to maximize the returns to our partners and to allocate capital
profitability toward growth initiatives of the company.
MISSION & VISION
What is Clinical Study?
 
“Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or
other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption, distribution metabolism, and excretion of an investigational
product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
synonymous. - ICH GCP”
Phase 0
or Micro
Dosing
Phase 1
1st in humans,
evaluates
safety,
determine a
safe dose, and
identify side
effects
Phase2
Evaluate safety
and efficacy on a
comparatively
large group
Phase 3
Tested on large
group of people
to confirm
safety, efficacy,
comparison
over existing
drug, quality of
life
Phase 4
Conducted after
marketing of drug
also called as
post marketing
surveillance
Clinical Trials Post Marketing Study
Discovery Phase
• B.Sc./ M.Sc. in Life Sciences/ Microbiology/
Biotechnology/ Zoology/ Biochemistry/
Chemistry/ Nursing
• B.Pharm/ M.Pharm
• BAMS/ BHMS/ BDS/ MBBS/ Physiotherapy
Who Can Participate in a CLINICAL
RESEARCH course?
• 6 Months Duration
• Comprehensive Syllabus of Clinical
Research, Pharmacovigilance and
Clinical Data Management Subjects
• Internship Opportunity
• Guest Lectures by Industry People
• Workshop on Interview Techniques
• CV Development
• Placement support Program
• Classroom Lectures
• Presentations & Discussions
• Assignments/ Projects
• Written Exam Based Evaluation
Highlights
Teaching
Methodology
Job Positions in Clinical
Research
•Clinical Trial Associate •Medical Coder
•Clinical Research
Coordinator
•Medical Writer
•Clinical Research
Associate
•Business Development
Executive
•Data Safety Associate •Quality Assurance
Associate
•Regulatory Associate •Trainer
•Investigator •Clinical Data Associate
CR Industry is in search
of…
- Qualified &
Competent People
- Relevant Education
in Clinical Research
- Good
Communication Skill
202 B, Park Plaza,
Karve Nagar, Pune,
India-52
+91 20 6560 1030
info@prorelix.com
Lifesciences Pvt. Ltd.
USA Partner:
Atlantis Clinical Trials
West Palm Beach, Florida, USA
+1 (561) 855 0645
atlantisclinicaltrials@gmail.com
UK Partner:
Cellomatics Biosciences
Biocity, Nottingham, UK
+44 (115) 787 0081
info@cellomaticsbio.com
“Interdependence is superior than dependence and
Independence’’
www.prorelix.com
Thank You!!

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Presentation of pro relix training

  • 1. Clinical Research Course by ProRelix Lifesciences www.prorelix.com | Lifesciences Pvt. Ltd.
  • 2. “ProRelix offer several professional, educational and informative services and resources for drug development and analysis on the industry to support clinical research. We specialize in a wide range of tools and resources to aid patient and investigator recruitment, remain current with industry trends and business practices, and strengthen organizational procedures. Our strong database and a fine assortment of industry resources make us an adept organization. In a highly fragmented industry, we are one of a group of organizations with the capability and expertise to conduct clinical research, on either a local or global scale. We have the operational flexibility to provide drug development services on a stand-alone basis or as part of an integrated full service solution.” “In a highly fragmented industry, we are one of a group of organizations with the capability and expertise to provide drug development services.” Relix | Lifesciences Pvt. Ltd.
  • 3. Mission To provide world class services to improve the quality of health care and reduce the efforts of our client in order to accelerate the overall process of drug development. We provide customized and effective solutions as per the needs and objectives of each task, all while complying with the highest international quality standards and practices. Vision As we move towards our goal of becoming a world class organization, our vision is to scale the great heights of innovation and outstanding services in order to maximize the returns to our partners and to allocate capital profitability toward growth initiatives of the company. MISSION & VISION
  • 4.
  • 5.
  • 6. What is Clinical Study?   “Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. - ICH GCP” Phase 0 or Micro Dosing Phase 1 1st in humans, evaluates safety, determine a safe dose, and identify side effects Phase2 Evaluate safety and efficacy on a comparatively large group Phase 3 Tested on large group of people to confirm safety, efficacy, comparison over existing drug, quality of life Phase 4 Conducted after marketing of drug also called as post marketing surveillance Clinical Trials Post Marketing Study Discovery Phase
  • 7.
  • 8. • B.Sc./ M.Sc. in Life Sciences/ Microbiology/ Biotechnology/ Zoology/ Biochemistry/ Chemistry/ Nursing • B.Pharm/ M.Pharm • BAMS/ BHMS/ BDS/ MBBS/ Physiotherapy Who Can Participate in a CLINICAL RESEARCH course?
  • 9. • 6 Months Duration • Comprehensive Syllabus of Clinical Research, Pharmacovigilance and Clinical Data Management Subjects • Internship Opportunity • Guest Lectures by Industry People • Workshop on Interview Techniques • CV Development • Placement support Program • Classroom Lectures • Presentations & Discussions • Assignments/ Projects • Written Exam Based Evaluation Highlights Teaching Methodology
  • 10. Job Positions in Clinical Research •Clinical Trial Associate •Medical Coder •Clinical Research Coordinator •Medical Writer •Clinical Research Associate •Business Development Executive •Data Safety Associate •Quality Assurance Associate •Regulatory Associate •Trainer •Investigator •Clinical Data Associate
  • 11. CR Industry is in search of… - Qualified & Competent People - Relevant Education in Clinical Research - Good Communication Skill
  • 12. 202 B, Park Plaza, Karve Nagar, Pune, India-52 +91 20 6560 1030 info@prorelix.com Lifesciences Pvt. Ltd. USA Partner: Atlantis Clinical Trials West Palm Beach, Florida, USA +1 (561) 855 0645 atlantisclinicaltrials@gmail.com UK Partner: Cellomatics Biosciences Biocity, Nottingham, UK +44 (115) 787 0081 info@cellomaticsbio.com “Interdependence is superior than dependence and Independence’’ www.prorelix.com