Clinical Research South Africa
Joint
position statement of the pharmaceutical industry and
clinical trial
Organisations on clinical trials in South Africa
Criterium’s
South African office is located at 7 Albury Park, Magalieszicht
Ave., Dunkeld West, Sandton, Johannesburg. The telephone
number is +27 11 325 5203.
Since Criterium’s African office
opened, it has been a major component of a global clinical
trial network and has provided clinical data for such
therapeutic areas as Seasonal Allergic Rhinitis, Malaria,
HIV/AIDS, Infectious Disease (herpes, pneumonia), GI,
Oncology, Cardiovascular and Pulmonary studies.
Criterium South Africa was established
in 2003 as Criterium’s first branch office outside
the United States. This was the first major step in
enabling Criterium to augment the real-time technology
used in its clinical trials with 24 hour study coverage.
The new office has increased value
to Criterium clients by enabling them to take advantage
of South Africa’s unique assets in the global
scenario of clinical research:
- Its location in the Southern
Hemisphere enables many clinical trials to be completed
unabated by considerations of seasonality,
- Large patient recruitment universe
populations in many therapeutic areas, due to its
unique mix of 1st and 3rd world economy
- An extremely well-established
mix of highly trained investigators and strict regulatory
standards for the conduct of clinical trials. South
African study data has long been a component of research
which has been granted FDA approvals.
Clinical Trials in South Africa
Criterium South Africa is currently
conducting National and Multi-National Clinical Trials
in the following Therapeutic Areas:
- HIV
- Dermatology
- Pediatric Pain
- Adult Pain
- Hematology
- Asthma
- Chronic Bronchitis
PREVIOUS THERAPEUTIC EXPERTISE:
The South African and sub-Saharan
region is increasingly more important to maintaining
strict timelines and cutting costs in the conduct of
clinical trials. Criterium South Africa personnel have
participated in over 75 clinical studies. We have provided
a variety of services including comprehensive study
management in many therapeutic areas, including:
SERVICE EXPERTISE:
All Criterium Clients benefit
from our unique and efficient technology-based workflow
structure. The South African office and field staff
are supported by centralized services in Criterium’s
USA headquarters where data-based Remote Study Management,
Data Management, Statistical Analysis, and Programming
Support are integrated to provide daily support to the
field team.
With experienced personnel (including
Board Certified Physicians) on the ground in South Africa,
Criterium Clients benefit from our thorough understanding
of the unique regulatory structures and specialized
patient requirements of this region. This enables us
to set aggressive timelines, reduce costs and produce
very high quality data when completing the clinical
trial process in South Africa. Because of the close
working relationship with headquarters, the data are
locked very soon after the last patient completes, facilitating
statistical analysis, final report and submission of
studies to the client and agencies.
Some of the specialized services
the Criterium South African office provides include:
Regulatory Services for South Africa and Sub-Saharan
Countries
- Preparation of Republic of
South Africa (RSA) product-specific regulatory strategies
and product development plans
- GCP training of sites, CRA’s
and sponsor CRA’s
- Regulatory guidance at all
stages of product development in RSA
- Planning, preparation, submission,
and maintenance of regulatory documents
- Interactions with Medicines
Control Council (MCC) regarding project specific issues
- Coordination, preparation
and participation in meetings with regulatory authorities
regarding product development issues.
- Protocol submission to MCC
for studies to be conducted in RSA
- Regulatory liaison activities
in RSA and other sub-Saharan African Countries
- Regulatory guidance at all
stages of product development
- Interactions with regulatory
authorities to coordinate inspection activities
- Maintenance and archiving
of clinical regulatory documents
- Support to product labeling
activities
Clinical Study Management:
- Phases I, II, III, IV and
observational study set up and monitoring
- Site solicitation, qualification
and management
- Investigator Meeting Organization
and Conduct
- Clinical Study Monitoring
in RSA and other sub-Saharan African Countries
- Medical Monitoring
- Pharmacy and Un-blinded Drug
Management
- Remote Study Management Using
Electronic Data Management and Monitoring Tools in
conjunction with Criterium Headquarters in USA
- IVR services for patient
registration, randomization and patient diary
collection
- Automated FAX scanning
of CRF’s, patient diaries, and quality of
life forms
- WEB-enabled forms (EDC)
- Real-Time Reporting, Visit
Report and Monthly Status Report
Pharmacokinetics/Pharmacodynamics – Local Phase
I / BE / BA Studies for:
- Access to healthy volunteers
with various ethnic backgrounds including Western
European, Indian, Asian and Black
- Access to special populations
such as HIV-positive, diabetes, and reduced liver
and kidney functioning
- Rapid interim PK analysis
- Noncompartmental PK and PD
analysis
- Toxicokinetic analysis
- Bioanalytical data review
- PK reports/contributions
- PK/PD modeling and simulation
Medical Writing:
- Fully integrated clinical
and PK/PD reports for electronic submission
- Marketing/regulatory documents
— writing and editing
- Protocol preparation
- SOP writing
- Investigator drug brochure
preparation and update
Program Management:
- Project Management for local
and international clinical studies
- Management and coordination
for study programs in which clinical aspects are conducted
at centers worldwide
- Clinical monitoring, data
management, biostatistics, programming and reporting
of every study provided in one agreed-upon format
- Creation and management of
global clinical pharmacology databases
- Overall program timelines
driven by regulatory submission
For more information on regulation
of medicines in South Africa visit the Medicines
Control Council website.
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