Clinical
Development
Being a company primarily staffed by physicians, it is natural that RxMD plays key strategic and execution roles in clinical development. To help one navigate the challenging journey from IND to commercialization, we provide clinical development services that focus on simple, economical solutions.
Our expertise in clinical development has spanned cutting-edge work in the areas of neglected disease, pediatric drug development and cell therapy.
Cell Therapy – Core Clinical Section Inputs
Sponsor developing novel cell therapy for induction of life-long immune tolerance in renal transplant recipients. RxMD rapidly assimilates into the clinical development team and contributes to key clinical sections of the IND, IB, target product profile, clinical development plan, study protocol and briefing book for special protocol assessment. During the development, RxMD demonstrates its neglected disease expertise in a novel setting (cell therapy).
RxMD requested to oversee leading CRO faltering in a large Phase II trial. RxMD makes decisions on eligibility, protocol violators and deviators based on non-inferiority nature of trial (primary efficacy analysis population = evaluable population) for successful conduct of trial, focused data review, database closure, interpretation of results and finalization of study report
Scientific Monitoring
Pediatric Clinical Development
Global big pharma requests assistance in pediatric development of asset for autoimmune indication. RxMD partners with leading clinical pharmacology and PK consulting firm to support sponsor. RxMD proposes innovative study designs to accelerate pediatric development, liaises with external and internal stakeholders and finalizes study design. RxMD leads authorship of clinical study synopsis and clinical aspects of Pediatric Investigation Plan (PIP) and Pediatric Study Plan (PSP). Sponsor considers replicating the processes/operating procedures (used for developing the PIP) for other assets, with RxMD leading pediatric clinical development.
In response to a public health crisis, RxMD quickly develops a protocol to evaluate an antiviral in infants. In a novel study design, employing its considerable pediatric drug development experience, RxMD makes allowances for both the gestational and postnatal age of infants, thereby allowing for appropriate exposure efficacy analysis. The study forms the basis for approval of the drug in infants in the U.S. and EU. Read the associated publication here.
Drug Development in Infants (less than one-year olds)
Study Management
Sponsor delegates to RxMD oversight of large Phase II non-inferiority clinical trial being conducted by premier CRO. RxMD successfully executes trial design, case report forms, database validations, scientific review of data, blinded signal detection, development of statistical analysis plan, identification of programming errors in blinded statistical outputs, interpretation of unblinded outputs and authoring of final study report.
RxMD, on review of biopharma SAP for Phase III superiority trial, notes that analysis for primary efficacy (Intent-to-treat, ITT) population does not account for visit windows, values outside windows, missing values, multiple values within windows, programming for major violations (exclusions from per protocol population), and inconsistencies between SAP and CRF design. RxMD recommends and implements changes on behalf of biopharma, and FDA concurs with SAP revisions.
Statistical Analysis Plan (SAP) Development
Novel Study Strategy
Sponsor consents to a post-approval commitment to establish efficacy in an immunocompromised population (precludes placebo control). RxMD establishes definition for immunocompromised population and designs trial using two active control arms to be compared with a placebo arm from the pivotal trial in healthy adults. Novel strategy meets with regulatory approval.
Client Speak
Joseph H. Hoffman, MD
It is a pleasure to commend RxMD to any pharmaceutical company, large or small, that is in need of additional medical support in pursuit of its clinical research objectives. When I was serving
Craig R. Rayner, PharmD, MBA
I cannot recommend highly enough the RxMD team. They have been my go-to pharmaceutical medicine and clinical safety team for more than a decade. We have worked closely on numerous development programs
Dror Rom, PhD
RxMD is a highly competent and experienced drug development team. It is comprised of some of the brightest and most creative professionals in the field, always thinking outside of the box
Our Clientele
We have worked for U.S. and EU-based big pharma & biotech, for small molecules, biologics & cell therapy, across indications.
