Alimentiv is your trusted advisor, applying our medical, statistical, regulatory and real-world insights to your clinical development strategy and clinical trial designs. By engaging early, as a strategic partner we enable biopharma organizations to clarify and define strategic objectives, assess and mitigate risks, accelerate plans and achieve desired outcomes
Clinical Development Advisory & Consulting
Alimentiv has been on the cutting edge of academic research excellence since 1986 and has an impressive track record in consulting on clinical trials in GI research and in trials evaluating the use of novel therapeutics. We are the pioneers in validating and implementing endoscopic and histologic central image scoring indices in IBD and we collaborate with a global network of experts in an outcome measures validation program and advocate for the implementation of these measures in clinical trials.
The aim of Alimentiv’s scientists is to design, test and teach high value strategies that deliver high quality outcomes and reduce development timelines and patient burden. We help companies investigate new therapies for patients as a one stop shop for data-driven medical and clinical trial methodology expertise.
Sample of What We Do:
- Advise in preparation for an End of Phase 1 FDA meeting; develop briefing document and participate in the meeting as a scientific expert
- Advise on Patient Reported Outcomes (PROs), histologic assessment tools and endpoints for use clinical development
- Advise on Phase 2 clinical trial program strategy and design
Leading With Science
Our Medical Research and Development team are not just experts in the design and conduct of clinical trials. We identify barriers to drug development and identify solutions to advance GI research.
- Statistical methodology assessment
and sample size calculation to maximize study efficiency
- Pragmatic and Adaptive statistical planning, design, simulation, execution
- Predictive modeling
- Validation of primary, secondary endpoints
- Causal Analyses –post-marketing
- Statistical Analysis Plans (SAPs)
- Data Quality Oversight through Quality Tolerance Limits and Statistical Monitoring Reports
Regulatory Submission Consulting
- Global regulatory strategy and submission plan develop
- Prepare and review regulatory agency meeting requests and packages