INTEGRATED PRODUCT DEVELOPMENT
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With our collective experience working in Early Phase Research, we can provide guidance on what is required, when, and how you can get there.
Given the dynamic nature of Early Phase Product Development, we can provide creative and adaptive solutions to match the evolution of your program. This adaptability and critical thinking comes with a highly experienced skill-set that we, as your partner, can bring to your pipeline development.
MEDICAL WRITING
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Clinical study design and strategy
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Protocol development
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Development of study wide documents such as Protocol and Investigator's Brochure
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Clinical Study Reports
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Manuscript development
PRODUCT DEVELOPMENT
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Clinical and Drug Development plans
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Gap analysis/review of scientific data to allow a smooth path to ethics committee approval
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Design of non-clinical animal studies and management of Toxicology CROs.
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Independent Toxicology Report Review and/or preparation to support ethics applications
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Statistical and Pharmacokinetic considerations of study design
REGULATORY
Behind every great clinical team stands great regulatory support!
Regardless of where you are, both geographically and in your development phase, we can provide you with expert global regulatory services, to provide a smooth integration of where regulatory meets product development, meets clinical. We understand not just getting you from A to B, but the space before A and then onwards to C. Some of the support services we provide are:
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Preparation of all modules of the Common Technical Dossier required for a Marketing Authorisation Application
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Organisation of Scientific Advice Meetings with Regulatory Agencies
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Preparation of Regulatory applications, such as pre-IND, IND, CTA, Orphan Drug Designations