From subjective endpoints with high rater variability, long follow-up, and small populations to caregiver-dependent recruitment challenges and strict scrutiny of disease-modifying evidence, neurology clinical research is uniquely demanding.
Caidya rises to the occasion with aligned endpoint strategy, operational execution, and evidence generation that keep you moving at the speed of science.
VP & Therapeutic Area Leader, Dermatology and General Medicine
With more than 28 years of experience in both pharma and CROs, Lori offers extensive experience in promoting data reliability, regulatory alignment, and patient recruitment, starting from early engagement through regulatory acceptance.
Chief Medical Officer
As chief medical officer, Dr. Sharon Moore is responsible for strategic development and medical oversight of the clinical studies, and oversees the medical affairs, pharmacovigilance, strategic regulatory and medical writing teams. She brings 28 years of industry experience in medical, safety, QA, regulatory, and training to her role to inform early phase trial design decisions, help achieve inspection readiness, and enhance governance rigor.
Dr. Sharon Moore - Chief Medical Officer
Slow endpoints, long durations, biomarker uncertainty, and complex recruitment aren’t problems with Caidya. Our approach combines clinical ops, data/biostats, and endpoint and regulatory expertise to:
We provide structured rater training and centralized quality oversight to standardize assessments, reduce inter-rater variability, monitor drift, and deliver reliable, consistent endpoint data across sites and over time.
We help reduce patient burden with caregiver-aware visit plans to support engagement, improve retention, and sustain participation.
We promote analytics readiness for slow disease progression with robust clinical trial data management, trajectory analyses, and consistent data capture.
We create recruitment strategies around the needs of rare and severe populations as we optimize site selection, patient identification, and enrollment pathways, improving your access and supporting realistic delivery
We cover you across clinical development, pre-IND/IND, Phase I-III, and post-marketing Phase IV studies with integrated and personalized services including:
Our experts optimize your trial because we know neurology, in and out. Our experience in the last five years alone includes:
We reduce inter-rater variability through structured rater training, certification, ongoing calibration, and centralized quality oversight to ensure consistent application of neurological rating scales across sites and over time.
We design endpoint strategies that account for slow progression by selecting sensitive measures, incorporating longitudinal assessments, and ensuring statistical plans can detect meaningful change over extended timelines.
We support retention through patient-centric design, reduced visit burden, caregiver engagement, flexible scheduling, and proactive follow-up strategies to maintain long-term participation and minimize dropout.
We use feasibility-driven site selection, targeted patient identification, and access-focused recruitment strategies, including remote and community-based pathways, to effectively reach rare and mobility-limited populations.
We integrate caregiver needs by evaluating how to simplify visit schedules, reduce logistical burden, and provide clear engagement pathways to support adherence, safety, and sustained participation in complex neurology studies.
We support Phase II decisions by integrating clinical, functional, and exploratory endpoints with longitudinal analysis to strengthen decision confidence when validated biomarkers are limited or unavailable.
We apply longitudinal modeling, trajectory analysis, and mixed-method data integration to interpret slow neurological decline and identify meaningful trends across extended study periods.
We build evidence packages that combine clinical endpoints, biomarker data (where available), and longitudinal analyses to support rigorous evaluation of disease-modifying effects under regulatory scrutiny.
We have supported neurology trials in Asia-Pacific, the EU, and North America.
We have supported several key indications, including Alzheimer’s disease, anti-MAG neuropathy, epilepsy, myasthenia gravis, pain, Parkinson’s disease, and spasticity.