You will be redirected to:

Continue
Logo - Kls
Logo - Kls
  • Playbook
  • Services
    Frame clinical development strategies
    Operationalize clinical development
    Implement RWE and Late Phase projects
    Enable life data science boosters
    Reach the next level in digital innovation
  • Insights
  • Technology
  • Careers
  • About us
    Company purpose
    Life science innovation
    Committed Keyrus
    Regulatory compliance
    Investors
    Management team
    Keyrus Group
    Locations

Medical device approved for Hearing Loss

Background

A Hearing Device sponsor needed Food & Drug Administration (FDA) approval to get their device on the US market. Keyrus Life Science had done a pilot study with the sponsor in conjunction with a CRO in France. The sponsor was happy with the work being done and asked KLS to continue in partnership.

Challenge

For the sponsor device study, only one study needed to be done for regulatory approval. That study was done in Canada. The device was approved in Canada. The challenge for their planned phase IV in the USA became: would data from Canada be enough for approval in USA? We helped them in supporting FDA submission, Sponsor's FDA Approval Process and improving site relationships based on sponsor's issues in past studies

Approach

Keyrus Life Science randomized all patients, gathered quality data, and prepared documents for FDA submission.

Key results

01
Strong Regulatory Documentation
02
Device approved in United States
03
Strong partnership developed between Keyrus Life Science and the sponsor

Benefits

Having learned from the pilot study, the sponsor believed the experience Keyrus Life Science had in Regulatory Affairs would be of benefit to their study.

Share this key play

whatsapptwitter
linkedinfacebookworkplace

More key plays

Piloting through a pivotal study in cataract eye surgery helping patients recover their vision
Accelerate the compliance process of your product portfolio in line with the new Medical Device Regulation (EU 2017/745)
Accelerate the clinical validation of an anti-Covid treatment, thanks to an agile data management
Lower costs & risks associated with indication extensions, thanks to a robust meta-analysis of clinical data
Adapting service platforms (FSP) functionning to fit the client's new outsourcing strategy
Facilitate the provision of an innovative treatment thanks to a Managed Access Program (MAP)
Efficiently conducting a worldwide phase 2 clinical study with multiple partners
Achieving an end-to-end audit approval from Health Canada
Facilitate data mapping to SDTM by leveraging standardisation and A.I.
Speed up the development of clinical study documents
Logo - Kls
Headquarters

157 Rue Anatole France 92593 Levallois-Perret

Phone:+33 (0)1 41 34 10 00

LinkedInKlsInstagram
PlaybookServicesInsightsTechnologyCareersAbout us
Company purposeLife science innovationCommitted KeyrusRegulatory complianceInvestorsManagement teamKeyrus GroupLocations
Legal notice & Terms of use
Privacy policy
Data protection