South Africa

Integrium South Africa
Your Gateway to Clinical Trials in Africa

Integrium South Africa (SA) is a well-established Contract Research Organization providing a comprehensive range of clinical research and development services to pharmaceutical, biotechnology, and device companies.

We provide integrated and turnkey clinical trial services and strategies in support of our sponsors’ clinical development and marketing objectives. Our strong capabilities, in-depth knowledge of the local market, and experienced staff make us an ideal partner for companies sponsoring clinical trials in South Africa and the larger region.

Services
Integrium SA provides a comprehensive range of services, including:

• Feasibility assessments
• Site recruitment and contract negotiation
• Project management
• Clinical monitoring
• Regulatory services
• Drug safety and medical services
• Drug management
• Vendor management
• Protocol development
• Key Differentiators

What makes Integrium SA stand-out as a CRO partner for South Africa?

• One-stop solution:
  Integrium SA offers comprehensive and integrated operational and clinical services to support and coordinate the main components of trial work scopes. Our relationship with Integrium in the USA, one of North America’s premier CROs for conducting clinical trials in cardiovascular and metabolic disease, provides Integrium SA with access to full-service multinational capabilities.
• Speed of start-up:
  Our in-depth knowledge & experience with regulatory processes enables us to efficiently navigate the approval process and ensure prompt site activation.
• Faster study completion:
  Our ability to recruit and motivate a network of high performing sites enables rapid enrollment and faster study completion.
• Cost:
  Integrium SA provides competitively priced services due to our efficient infrastructure and wide network of regionally-based monitors. By in-sourcing specialized resources that already exist in South Africa, clients pay only for the CRO services they require and not for the hidden costs of a heavy infrastructure.
• Confidence:
  Our ability to conduct thorough feasibility analysis, develop contingency plans, and maintain vigilance throughout the study enables confidence among our sponsors that we are properly prepared and are proactive when challenges arise. The team has the “local” expertise to guide sponsors through the unique clinical trial landscape and regulatory process in the country.
• Personal Service:
  We establish and sustain a high level of attention and visibility to every workscope throughout the duration of the project and provide optimal communication due to the manageable size of organization.
• Quality:
  We ensure high quality by selecting the best available research sites, investigators and monitoring staff, and by working in strict accordance with ICH & South African GCP Guidelines and established metrics for monitoring services.
• Flexibility:
  We have the ability to take on global “megatrials,” but remain flexible enough to provide an individual, highly personalized service for locally managed projects. We adapt our approach as customer requirements change.

Why Conduct Your Trial In South Africa?

South Africa has become a popular region for conducting clinical trials and has earned a reputation for excellence in clinical research. South Africa is the powerhouse of Africa - with the most advanced, broad-based economy on the continent - and has a strong infrastructure in the medical sciences.

There are compelling reasons for sponsors to conduct clinical trials in South Africa:

High-Quality Infrastructure

South Africa has an extensive pool of experienced and well-trained investigators, and offers state-of-art facilities and medical technology. Clinical trials are conducted in compliance with ICH/GCP standards and produce high-quality data widely accepted by FDA and EMEA.

Access to Patients

South Africa has a total population of over 47 million people of diverse origins, cultures, languages, and beliefs. Conducting trials in South African allows for access to large numbers of patients across a range of major therapeutic areas and indications, many of whom have not previously received treatment.

This provides sponsors with the benefit of rapid patient enrollment of their trial. Additionally, a high retention rate and compliance level minimizes patient withdrawals. Patients very willing to participate in clinical trials because they receive regular medical care and at no cost.

Prevalent diseases in South Africa include:

• Cancer
• Congestive Heart Failure, Myocardial Infarction, Hypertension, and Dyslipidemias
• Community Acquired Pneumonias
• Dementias, Epilepsy
• Diabetes
• Crohn’s Disease, IBD
• Malaria, TB, and HIV
• Respiratory Diseases
• Sexually Transmitted Diseases

Cost

While South Africa has a modern first-world medical infrastructure, the costs for travel, accommodations, investigator grants, and printing are significantly lower in South Africa when compared to clinical trials conducted in Europe or North America. This provides sponsors with a cost-effective solution to accrue patients for their trial programs.

Experience

At Integrium SA, we believe that our greatest strength and most valuable resource is our people. Our personnel include some of the industry’s most experienced professionals and it is Integrium SA’s policy to employ highly-qualified and seasoned individuals across all disciplines.

The Integrium SA operation is led by Dr. Andrew Jacovides – a clinical researcher who has conducted over 140 clinical trials – and Nicolette Muller – the operations manager with 10 years of experience managing clinical trials.

Integrium SA’s clinical team offers strong experience in clinical research management, clinical practice, and regulatory affairs.

Collectively our staff has a broad range of therapeutic area experience, including:

• Respiratory
• CNS & Psychiatry
• Cardiovascular
• Endocrine
• Infectious Diseases
• Oncology
• GIT
• Other TAs (Dermatology, Nephrology, Vernal Keratoconjunctivitis, Iron overload, Pediatric)

We have an established track record of success supporting workscopes for a range of clients - from large multinational pharmaceutical companies to smaller biotech and pharmaceutical companies.

Contact Us

Contact Email: info@integrium.com

Integrium South Africa

Health Emporium Integrium,
Shop # 17, Cnr. Church & Market Streets
Halfway House 1685, South Africa

Nicolette Muller,
Clinical Operations Manager
27 11 315 5122 direct phone
27 11 315 5097 main phone
Nicolette.Muller@Integriumsa.co.za or SouthAfrica@Integrium.com
(Central African Time Zone GMT +2hrs)

Integrium US

Greg Dodds,
Vice President,
Business Development

Tel +1 (860) 668-0810
Mobile +1 (908) 448-9131
Greg.Dodds@Integrium.com
(Eastern Time Zone GMT – 5hrs)