Our projects

Our global consultants work in major medical institutions around the world, addressing some of the most difficult challenges in healthcare. We focus on life-threatening illnesses with an emphasis on understanding toxicity, dose modifications, adverse event profiles and disease progression.

Our team includes RECIST 1.1 experts, with specialists in Solid Tumour (Skin, Colon, Prostate, Breast) and Haematological (CLL, MCL, Multiple Myeloma) conditions

Our African and South African CRAs have a unique understanding of how to operate within the confines of a challenging environment. We address global health challenges that face resource-limited funding or demanding logistics.

Our consultants based in East Africa (Kenya, Nairobi) and South Africa can navigate third-world infrastructure with the tools and awareness that contribute to innovative solutions, as demonstrated by our anti-malaria project for pregnant women in Tanzania.

Our Quality Managers provide strategic and tactical development, execution and management of the Clinical Operations Clinical Quality Management Programme within major global pharmaceutical companies.

They oversee development of GDP compliance activities and training curricula, clinical trial quality management plans and processes, Clinical Operations SOPs and other process guidance documents.

Our experts also provide strategic planning, preparation and support for Regulatory Authority GCP sponsor, clinical site and clinical vendor inspections

Our GCP Quality Control consultants work on multiple Oncology and Rare Disease projects all over the world. They can adapt to different cultures and provide a bird’s eye view of what is happening on site. They are trained to spot problems, risks and misconduct that clients may not be aware of, evaluating the protocol and then assessing areas where damage control may be needed to avoid problems and expenses.

They also provide mentoring, training, assistance with CAPA and in-depth analysis of on-site trends and CRO performance, making them a real investment in quality and oversight.

Our specialists can schedule days on site, independent of the CRA, so that time is spent with the appropriate staff to clear up action items, provide instruction and deliver training where needed. They work with the site in a variety of ways, with the goal of clearing a path so the CRA can focus on their role, data cleaning and TMF.

Our site specialist can then work in tandem with the CRA to build a rescue plan, working towards compliance with study metrics, well-reviewed data and a smooth-running study.