Cardiac Safety Consultants
Cardiac Safety Consultants Ltd is an independent UK-based consulting partnership providing expert cardiac safety advisory services — including TQTc study design, ECG interpretation, biomarker assessment, and FDA/EMEA/PMDA regulatory support — to pharmaceutical and biotechnology companies running clinical drug development programs worldwide.
- Company typePrivate
- Founded2008
- HeadquartersLondon, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Cardiac Safety Consultants does
Cardiac Safety Consultants Ltd is a privately-held European consulting group, founded in 2008 and domiciled in the United Kingdom, that provides independent cardiac safety advisory services to pharmaceutical and biotechnology companies involved in clinical drug development. The firm operates as a small expert partnership — its public-facing principals are Dr Boaz Mendzelevski (cardiologist, founder of the first European CRO ECG lab at the Royal Brompton Hospital, ex-Director of Cardiology at Covance Inc., currently Director of Cardiology at Medifacts International), Dr Borje Darpo (member of the ICH E14 Expert Working Group and EFPIA topic leader), and Dr Dennis Chanter (biostatistician, ex-Head of Statistics at Quintiles with a specialist focus on QT prolongation) — and positions itself as fully independent of phase 1 units, core ECG labs, and contract research organizations.
Its core offering is project-based professional consultancy rather than a software platform. Services span the full translational medicine spectrum: protocol design and development (including TQTc study design, analysis, reporting, and regulatory discussion); expert clinical reports for regulatory submissions; global regulatory advice covering the FDA, EMEA, and PMDA; drug due diligence for in-licensing and out-licensing decisions; independent advisory board support; and independent global cardiovascular monitoring including biomarker assessment across serum, imaging, and electrocardiographic modalities. The underlying 'technology' is the deep clinical, regulatory, and statistical expertise of its named consultants, supported by downloadable educational resources (CSC Flyer, Biomarkers presentation, EPC Articles, Unresolved QT Issues presentation) hosted on the corporate website.
The revenue model is professional services delivered on a quote-based consulting engagement basis, sold directly to enterprise pharmaceutical and biotechnology clients globally (with active coverage in Europe, the United States, and Japan). The firm does not disclose pricing, customer counts, revenues, funding, or headcount, and it has no disclosed parent company, subsidiaries, or institutional investors. Marketing is conducted through a content-led website channel supplemented by direct enterprise field sales engagement, and the company's stated differentiators are independence from CROs/labs, regulatory authority via ICH E14 involvement, and the combined seniority of its three lead consultants.
Cardiac Safety Consultants firmographics
Firmographics- Name
- Cardiac Safety Consultants
- Legal name
- Cardiac Safety Consultants Ltd
- Website
- https://cardiacsafetyconsultants.com
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Cardiac Safety Consultants Ltd is an independent UK-based consulting partnership providing expert cardiac safety advisory services — including TQTc study design, ECG interpretation, biomarker assessment, and FDA/EMEA/PMDA regulatory support — to pharmaceutical and biotechnology companies running clinical drug development programs worldwide.
- Ownership category
- akta.pro rank
Cardiac Safety Consultants industry classification
Industry- Product category
- Pharmaceutical Cardiac Safety Consulting
- NAICS
- Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Imaging & Cardiac Safety Core Labs (ECOG/EEG/ECG) (HLAGAAAJ)
- akta.pro secondary industry
- PV Regulatory Submissions & Safety Reporting (E2B/CIOMS/Expedited) (HLAGALAJ)
Keywords
Where Cardiac Safety Consultants is headquartered
LocationHeadquarters
- HQ city
- London
- HQ country
- United Kingdom
- HQ region
- Europe
Markets served
Cardiac Safety Consultants business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Consulting Services: Project-based consulting engagements providing expert cardiac safety advisory services to pharmaceutical and biotechnology companies. Services include protocol design, TQTc study support, regulatory submissions, and cardiovascular monitoring for clinical trials.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels1 record
Cardiac Safety Consultants product offering
Product offeringCore offering
Cardiac Safety Consultants Ltd is an independent European consulting firm that provides expert advisory services to pharmaceutical and biotechnology companies on cardiac safety aspects of drug development. The core offering covers protocol design (including TQTc study design, analysis, reporting and regulatory submission), expert clinical reports for regulatory submissions, global regulatory advice spanning FDA, EMEA, and PMDA requirements, drug due diligence for in/out-licensing, independent advisory board support, and independent global cardiovascular monitoring including biomarker assessment.
Product overview
Cardiac Safety Consultants is a European consulting firm offering a unified portfolio of consultancy services rather than a software product platform. The core offering comprises expert consultancy services for cardiac safety in drug development, supported by specialized modules including global regulatory advice (FDA, EMEA, PMDA), independent cardiovascular monitoring with biomarker assessment, drug due diligence, and expert clinical report preparation. The consultancy is led by Dr Boaz Mendzelevski (Director of Cardiology), Dr Borje Darpo (cardiac safety advisor), and Dr Dennis Chanter (biostatistician), providing integrated expertise across clinical cardiology, regulatory affairs, and statistical analysis.
Differentiator
Problem solved
Functional benefit
Companies that use Cardiac Safety Consultants
Customer profileSegments2 records
Ideal customer profiles2 records
Cardiac Safety Consultants technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Cardiac Safety Consultants partnerships and signals
Strategic signalScale indicators1 record
Recent moves4 records
Expansion highlights4 records
Cardiac Safety Consultants competitors and assessment
Company assessmentBroad incumbents
- Parexel International: Global CRO with cardiac safety and clinical pharmacology expertise across early- and late-phase development. Broad incumbent that competes for sponsor cardiac safety advisory work as part of full clinical delivery packages.
- Inotiv: Preclinical and safety pharmacology CRO including cardiovascular safety assessment capabilities. Comparable as a broader incumbent in cardiac safety assessment across the drug development spectrum, particularly for sponsors needing both preclinical and clinical cardiac safety coverage.
- Covance (now Labcorp Drug Development): Global CRO offering integrated cardiac safety, ECG core lab, and clinical development services. Broad incumbent comparable because Dr Mendzelevski previously served as Director of Cardiology at Covance, illustrating direct service-line overlap.
- Charles River Laboratories: Major CRO offering preclinical safety pharmacology (including cardiovascular safety assessment) and clinical cardiac safety services. Comparable as a broad incumbent offering overlapping cardiac safety expertise, particularly on the preclinical-to-clinical translational boundary CSC also covers.
- Quintiles (now IQVIA): Global full-service CRO with a large cardiac safety division including ECG core labs and QT-prolongation statistical services. Broad incumbent that competes on integrated cardiac safety consulting as part of larger Phase II–IV delivery; Dr Chanter previously headed statistics at Quintiles.
- PPD (now Thermo Fisher Scientific PPD): Global CRO with cardiac safety, ECG core lab, and QT-interval assessment capabilities. Broad incumbent that competes for the same pharma/biotech sponsor cardiac safety consulting engagements CSC pursues.
Direct peers
- Medifacts International: Cardiac safety core lab specialising in ECG core laboratory services and QT/TQTc analysis for clinical trials. Direct peer because Dr Mendzelevski serves as Director of Cardiology at Medifacts while simultaneously leading Cardiac Safety Consultants, indicating substantial service-line overlap.
- ERT (now Clario): Cardiac safety core lab and eCOA provider offering centralised ECG, Holter, and TQTc study services to pharmaceutical sponsors globally. Direct peer with the broadest installed base in cardiac safety core lab services and competes with CSC for protocol-design and analysis engagements.
- iCardiac Technologies: Specialist cardiac safety core lab offering thorough QT study design, Holter analysis, and ECG-based cardiac safety analytics for pharma/biotech trials. Closest direct competitor to CSC on dedicated TQTc and cardiac safety consulting for early-phase programmes.
- BioClinica (now Clario): Cardiac safety and imaging core lab services for clinical trials, including ECG, MUGA, and echocardiography. Direct peer competing for the same sponsor cardiac safety consulting and core lab work CSC addresses.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks5 records
Key highlights5 records
Customer concentration
Cardiac Safety Consultants social profiles
Digital presenceCardiac Safety Consultants financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cardiac Safety Consultants leadership team
Management profileNumber of profiles
Profiles3 records
Cardiac Safety Consultants funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cardiac Safety Consultants M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Cardiac Safety Consultants
What does Cardiac Safety Consultants do?
Cardiac Safety Consultants Ltd is an independent European consulting firm that provides expert advisory services to pharmaceutical and biotechnology companies on cardiac safety aspects of drug development. The core offering covers protocol design (including TQTc study design, analysis, reporting and regulatory submission), expert clinical reports for regulatory submissions, global regulatory advice spanning FDA, EMEA, and PMDA requirements, drug due diligence for in/out-licensing, independent advisory board support, and independent global cardiovascular monitoring including biomarker assessment.
Is Cardiac Safety Consultants a public or private company?
Cardiac Safety Consultants is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Cardiac Safety Consultants founded?
Cardiac Safety Consultants was founded in 2008. It employs 11 to 50 people.
Where is Cardiac Safety Consultants based?
Cardiac Safety Consultants is headquartered in London, United Kingdom, in the Europe region.
How does Cardiac Safety Consultants make money?
One revenue line is on record: consulting Services.
Who are Cardiac Safety Consultants's main competitors?
Broad incumbents on record are Parexel International, Inotiv, Covance (now Labcorp Drug Development), Charles River Laboratories, Quintiles (now IQVIA) and PPD (now Thermo Fisher Scientific PPD). Direct peers are Medifacts International, ERT (now Clario), iCardiac Technologies and BioClinica (now Clario).
Does Cardiac Safety Consultants have an API?
No public API is recorded for Cardiac Safety Consultants.
What industry is Cardiac Safety Consultants in?
Cardiac Safety Consultants's product category is Pharmaceutical Cardiac Safety Consulting. Its primary akta.pro industry code is HLAGAAAJ, Imaging & Cardiac Safety Core Labs (ECOG/EEG/ECG), with a secondary code of HLAGALAJ, PV Regulatory Submissions & Safety Reporting (E2B/CIOMS/Expedited). Its NAICS code is 5417 and its SIC code is 8731.