Evidence library
Every figure, and where it comes from
Regulated buyers check claims for a living. So every number on this site carries a tag that links here, and our own figures are labelled as our own.
1 Published external source9 MedicOrbis internal figureHow we cite
Published external sources
Peer-reviewed studies, regulator records, company disclosures and industry surveys.
- 1
Tufts Center for the Study of Drug Development. The Value of a Day of Delay in Drug Development, white paper, August 2024.
A day of delay is worth about $800,000 in lost prescription sales, and a Phase II or III trial costs about $40,000 per day.
- 2
Chahal HS, Mukherjee S, Sigelman DW, Temple R. Contents of US FDA Refuse-to-File Letters for New Drug Applications and Efficacy Supplements. JAMA Internal Medicine, 2021; 181(4): 522-529.
Analysis of 2,475 applications, 2008 to 2017.
- 3
US FDA. Electronic Common Technical Document; Data Standards; Specifications for eCTD Validation Criteria. Federal Register, 30 August 2021.
Technical Rejection Criteria for study data, enforced from 15 September 2021.
- 4
US FDA Warning Letter to Novo Nordisk, 5 March 2026, following inspection of 13 January to 7 February 2025.
Cited failures to meet postmarketing adverse experience reporting requirements. Reported by CBS News, Healio and Pharmaceutical Technology, March 2026.
- 5
MedTech Europe. Report on Administrative Burden under IVDR and MDR, March 2025.
Industry survey of European medical device and IVD manufacturers.
- 6
Transforming Medical Regulations into Numbers: Vectorizing a Decade of Medical Device Regulatory Shifts in the USA, EU and China.
Dataset of 664 regulations and guidelines across the three jurisdictions over the past decade, to 2024.
- 7
Philips Respironics consent decree, agreed with the US Department of Justice and FDA on 29 January 2024 and entered by the US District Court (W.D. Pa.) in April 2024.
Company disclosure.
- 8
Philips agreement of 29 April 2024 to pay USD 1.1 billion to resolve US personal injury litigation and the medical monitoring class action.
Koninklijke Philips NV filings (Form 6-K, SEC EDGAR) and contemporaneous press coverage.
- 12
Clinical-research system sprawl, industry reporting by eClinical Solutions and Clinical Technology Leader.
Sites run six or more separate systems per study, more than fifteen on complex trials, and a majority of trials are hindered by multiple disconnected systems.
- 13
Tufts CSDD clinical site-initiation benchmark, reported in Clinical Leader, 30 May 2017.
Site start-up averages about 31 weeks and 11 per cent of sites never activate. A 2017 finding.
MedicOrbis internal figures
These describe our own configuration, our own assessment and our own prices. They are not independent evidence, and we do not present them as such.
- 9
MedicOrbis live platform configuration, August 2026.
Process, stage, module and jurisdiction counts are read directly from the running platform, not estimated.
- 10
MedicOrbis Top-60 Process Analysis, August 2026.
Manual-effort hours, current-state elapsed times and automation-reduction ranges are assessed per process and shown as ranges, not point estimates. Your own baseline replaces them in a pilot.
- 11
MedicOrbis price list, 2026.
Entry pricing is indicative and scoped against each client's portfolio, jurisdictions and user population.
Regulatory enforcement is described as what the regulator found or alleged. A warning letter or a consent decree is a finding about process and reporting, and is not a conclusion that a product caused harm.