Late Phase II - IV Services
SGS is aware that although the transition from early to late phase clinical trials is a mark of success, it is also a point of increased risk: in cost, recruitment and logistics. Our Late Phase II–IV Services aim to mitigate those risks and provide you with a partner to guide you throughout Phase II, III and IV clinical trials.
With the knowledge and skills gained from over 30 years’ experience of conducting over 1,000 late phase clinical trials across the globe, we have created a suite of services that work as a comprehensive clinical trial consulting package or as standalone services to call on as you progress from research to market:
- International and local trial management and monitoring
- Consulting for full clinical development programs
- Regulatory guidance for global trials
- Study design and protocol writing
- Country specific feasibility studies
- Clinical site evaluation and selection
- Pharmacovigilance services
- Data management and biostatistics.
Should you ask SGS to design and implement a complete clinical trial program, we will consult our own regulatory group and other opinion leaders on how best to achieve your objectives, giving you access to cutting-edge thinking and techniques and making sure the most appropriate sites and countries are included.
We have particular therapeutic expertise in programs dealing with infectious disease and viral infections, cardiovascular indications and the central nervous system, but our work is not restricted to these areas.
When it comes to pivotal clinical research outsourcing, SGS is the supplier of choice for organizations of all sizes. It is the combination of world-class service provision and our commitment to integrity and quality that puts us ahead of our competitors. Our consultants are available to discuss how we could shape a late phase clinical trial program that meets your business needs. Email us
FDA GuidanceAntiretroviral Drugs for HIV-1New FDA Industry Guidance For Developing Antiretroviral Drugs For Treatment Of Human Immunodeficiency Virus-1 (HIV-1) InfectionIn the Summer of 2013 the FDA issued draft guidance for the industry development of antiretroviral drugs for HIV-1 infection. ... PK/PD ModelingModel Based Drug Dev'tThe FDA ‘‘critical path’’ document characterizes model-based drug development (MBDD)A less formal description of MBDD would be the development and use of mathematical models to aid answer existing and future project team questions ...
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