What are Clinical Studies?

When you participate in a clinical study, you help us develop more effective medicines and treatments.

Introduction:

Synexus Clinical Research SA (Pty) Ltd (Synexus SA) part of the Synexus group of companies, is a very successful Site Management Organisation that recruits patients and conducts clinical studies for pharmaceutical companies.

Synexus Clinical Research SA is dedicated to a professional and personal approach in the performance of high quality clinical research.

What are Clinical Studies?

Clinical Studies are studies conducted to evaluate the safety and effectiveness of new medications.  Before a new treatment can be approved, it must be tested thoroughly according to strict guidelines established by the Medicines Control Council (MCC).  Before a study is implemented, an Ethics Committee and the MCC must approve the study and the protocol.  These approvals ensure that each study will be conducted under strict ethical guidelines and that the safety and well-being of the patients, are protected.  Therefore, we at Synexus Clinical Research SA can assure you that, although a study is a scientific procedure, we will always have your interest, health and safety ethically protected because you are very important to us.

Research and Development of new chemical entities:

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 Research:	Â	Â	Â	 Discover it
 Technical:	Â	Â	Â	 Make it
 Safety:	Â	Â	Â	 Test it: Pre-clinical (In the lab and Phase I studies)
 Medical:	Â	Â	Â	 Test it: Humans (Phase I - IV studies)
 Regulatory:	Â	Â	Â	 Register it
 Commercial:	Â	Â	Â	 Sell it

 

The "Safety" and "Test it" phases of Drug Development:

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  Phases:Â	Â	Â	Â	  What is it being tested for:
  Phase I	Â	 Â	Â	  Initial Safety: Tolerability in humans
  Phase II	Â	Â	Â	  Early efficacy, dose finding in humansÂ
  Phase III	Â	Â	Â	  Efficacy and Safety in humans
  Phase IV	Â	Â	Â	  Marketing Studies

Participation, in clinical studies, is completely voluntary.  You can also, at any stage during a study, voluntarily withdraw.

Synexus Clinical Research SA conducts studies in following therapeutic areas:

Vaccines
Infectious diseases
HIV
Diabetes and Endocrinology
Respiratory allergies
Surgical / Post operative
Cardiovascular
Rheumatology
Devices / other
Osteoporosis
Women's Health
Gout