FAQ
Study Design and Project Management: CHIMunomics has extensive experience in clinical design and implementation e.g. protocol writing, feasibility.
Consultancy Data analysis and RCT outcomes: Our experts can analyse study data; identify significant outcomes; assist with presentation of data and advise on next steps for product development (strategic advice packages).
Clinical Trial Management: The team can help manage your clinical trial from initiation through to writing the CTR.
Regulatory Advice: We offer help with scientific advisory meetings; informed discussions with the FDA / EMA and MHRA and optimal trial design and implementation according to successful precedents and proven pathways.
It can be both expensive and time consuming as well as inefficient to semploy permanent staff to undertake elements of drug and vaccine development that are 'stand-alone' or single episode elements.
It can be both expensive and time consuming as well as inefficient to employ permanent staff to undertake elements of drug and vaccine development that are 'stand-alone' or single episode elements.
Scalable contracts to deliver critical documents, guidance or project management can reduce overheads and increase quality where expert services can be accessed.
An NDA/CDA can be quickly and securely be put in place to discuss specific needs with no cost or expectations.
Knowledge – Decades of experience in ‘leading CROs’ as well as Pharma and Biotechs/Start-Ups, offering consultancy to all levels in designing and overseeing RCTs and translating clinical and non-clinical outcomes.
Dependability – Previous successful track record in both generating and interpreting data to progress products and attracting onward investment.
Quality – CHIMunomics is grounded in ‘Quality First’. Your company and your ambitions matter to us, we listen, research and understand the environment and data before we offer the best solution for your product according to your circumstances and need.
Speed – Experienced team members are able to take away the burden of micromanaging processes or data interpretation to provide a packaged solution for better product progression.
Service – CHIMunomics stands for personal service. The customer comes first. Choose your deliverables and let us advice and implement.
The infamous valley of death in early biotech product development is due, to a large part, to inadequate translation of pre-clinical data into clinical indications/trial design and the definition of achievable outcomes and endpoints.
Definition of outcomes and endpoints with a focus on topline result press releases after completion of a trial that may attract new funding is a rare skill* possessed by the CHIMunomics team.
Large Pharma often supports multiple teams with diverse skills with almost inevitable communication problems and a concomitant lack of understanding or recognition of accountability. Early biotechs may be led by teams with a narrow range of expertise in pre-clinical and academic trial design only.
The amount of information that needs to be provided in IMPDs/Study Synopses and Protocols, putting aside communications concerning the study with regulatory agencies, may promote unintentional errors and lead to regulatory agencies imposing unnecessary and often complicating provisos.