Advances in the medical device industry have led toa substantial increase in developmental complexity, clinical trial conduct, andstringency of regulatory review, causing sponsors to rely on the technical andregulatory affairs management expertise of CROs
The report features an extensive study of thecurrent market landscape and future opportunities of contract researchservice providers focused on medical devices. The study also features anin-depth analysis, highlighting the capabilities of the various stakeholdersengaged in this domain, across different regions of the globe. In addition toother elements, the study includes:
§ Adetailed review of the overall landscape of medical device CROs.
§ Anelaborate discussion on the various guidelines established by major regulatorybodies for medical device approval across North America, Europe, andAsia-Pacific and rest of the world.
§ Elaborateprofiles of key players that specialize in offering services for both clinicaland preclinical stage development of medical devices.
§ Ananalysis highlighting the key performance indicators used by sponsor companiesto evaluate service providers engaged in this domain
§ Acompetitive benchmarking, highlighting the key focus areas of small, mid-sizedand large companies, comparing their existing capabilities within and beyondtheir respective peer groups.
§ Adetailed brand positioning analysis of leading industry players (shortlistedon the basis of strength of service portfolio).
§ Adetailed geographical clinical trial analysis of ongoing and planned studiesrelated to medical devices.
§ Adetailed analysis of the mergers and acquisitions that have taken place in thisdomain during the period 2015-2020.
§ Asurvey analysis featuring inputs solicited from various experts who aredirectly / indirectly involved in providing contract research services tomedical device developers.
§ Adiscussion on affiliated trends, key drivers and challenges, under a SWOTframework, which are likely to impact the industry’s evolution.
§ Anelaborate discussion on the future opportunities / trends for the medical deviceoutsourcing market that are likely to influence the growth of this domain overthe coming years.
§ A detailed market forecast, featuring analysis of thecurrent and projected future opportunity across key market segments (listedbelow)
- Phase of Development
§ Types of PreclinicalServices Offered
§ Sterility andmicrobiology testing
§ Materialcharacterization and analytical services
§ Types of ClinicalServices Offered
§ Clinical trialmanagement
§ Data management
§ Regulatory affairsmanagement
§ Device Class
§ Class I medicaldevices
§ Class II medicaldevices
§ Class III medicaldevices
§ Target TherapeuticArea
§ CNS disorders
§ Oncological disorders
§ Bone disorders
§ Respiratory disorders
§ Pain managementdisorders
§ Ophthalmic disorders
§ Metabolic disorders
§ Key GeographicalRegions
§ North America
§ Rest of the World
§ Transcripts ofinterviews held with the following senior level representatives of stakeholdercompanies
§ Lajos Sarosi (ChiefExecutive Officer and Co-founder, HungaroTrial)
§ Christopher Rupp(Vice President of Global Marketing and Commercial Operations, NAMSA)
§ Christian Wolflehner (GeneralManager, CW Research & Management)
§ Troy Mccall (ChiefOperating Officer, CROMSOURCE)
§ Nazish Urooj (Seniormanager, Medical & Clinical Operations, Metrics Research)
§ C. Omprakash (TechnicalDirector and Partner, Vyomus Consulting)
§ Tania Persson (Directorof Business Development, A+ Science)
§ Alexa Foltin-Mertgen (BusinessDevelopment Manager, AtoZ-CRO)
Keycompanies covered in the report
§ Avania (formerlyknown as Factory CRO)
§ Charles RiverLaboratories
§ CSSi LifeSciences™
§ Eurofins Medical DeviceTesting
§ IMARC Research
§ Qserve Group
§ Regulatory and ClinicalResearch Institute (now a part of Covance)
§ WuXi AppTec
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