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… Clinical Trials With broad therapeutic experience across all phases of … for clinical trials, including: Protocol and statistical analysis plan (SAP) development Sample size calculations Randomization Interim and final data analyses Clinical Study Reports (CSR) Support for …
… Psychometric Evaluation Our psychometricians have extensive experience … as facilitating the interpretation of results in terms of responder definitions and minimal important difference values to support FDA and EMA submissions or guide decision making in routine …
… patient differences. In fact, by design, randomized clinical trials aim to factor out (through randomization) individual … II - Refine patient exclusion/inclusion criteria - Refine responder definitions - Power Phase III and recruit …
… New FDA Draft Guidance For Evaluating Patient-Reported Outcomes … Outcome Instruments for Use in Medical Device Evaluation.” While its title suggests that the draft … based on whether the instrument supports a study’s primary endpoint, inclusion criteria, or a safety outcome. When …
… Multi-Criteria Decision Analysis Most drug development and commercialization choices … for each target market or country. With access to clinical trial data, outcomes data, and published economic models, we can …
… Studies Beyond the evidence standards set by traditional clinical trials, well-designed and implemented surveys and … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon … International Society for Pharmacoepidemiology (ISPE), the FDA, the EMA, and the European Network of Centres for …
… Webinar: Characteristics of Recent PRO Labeling by the FDA and EMA for Oncology Drugs Share on: Wednesday, March 13 … evaluate evidence from patient-reported outcomes (PROs) in clinical trials. Study sponsors pursuing PRO drug labeling …
… indications Determine health economic endpoints for your clinical trials Analyze economic data collected in clinical trials … methodology—whether a decision model , chart review , analysis of healthcare claims , literature review, or …
… RWE Studies Using Primary Data Collection To meet the requirements of risk management … coordinating center: Developing protocols Writing analysis plans and performing analyses Writing reports and … Leading and coordinating: Scientific advisory panels Endpoint adjudication committees Steering committees …
… FDA Rare Disease Day 2024 Virtual Public Meeting Share on: … of certain groups of otherwise eligible subjects in clinical trials. This panel also includes discussion of … experience in the rigorous development and psychometric evaluation of clinical outcome assessment measures for use in …