Dr. Notghi Contract Research
Berlin-based contract research organization (CRO) founded in 1999 offering end-to-end services for clinical studies, pharmacovigilance, post-market surveillance and regulatory consulting for medicines, medical devices and IVDs. Services include study design and monitoring (ICH-GCP/ISO 14155), safety case management and reporting, clinical evaluation and PMCF for devices under EU MDR, systematic literature reviews, medical writing and GCP training. The company also implements digital pharmacovigilance monitoring of online and social media channels and supports PSUR and benefit-risk reporting.
Industries
Nr. of Employees
small (1-50)
Dr. Notghi Contract Research
Services
Operational management of interventional and non-interventional clinical studies including protocol review, site monitoring and data handling.
Adverse event intake and processing, timely reporting, periodic safety reports, risk management plans, PV documentation maintenance and PV audits.
Implementation and operationalisation of digital-channel monitoring for safety signals, automated screening and configurable delivery of findings to PV teams, PV databases or authorities (including structured XML export).
PMS and vigilance services under EU MDR including PMS/PMCF planning and reporting, safety/performance data collection and incident reporting.
Preparation of clinical evaluations, PMCF study design and reports to demonstrate continued device performance and safety.
Assessment of publication obligations, preparation and publication of protocol and result data to registries and authorities.
Operational management of interventional and non-interventional clinical studies including protocol review, site monitoring and data handling.
Adverse event intake and processing, timely reporting, periodic safety reports, risk management plans, PV documentation maintenance and PV audits.
Implementation and operationalisation of digital-channel monitoring for safety signals, automated screening and configurable delivery of findings to PV teams, PV databases or authorities (including structured XML export).
PMS and vigilance services under EU MDR including PMS/PMCF planning and reporting, safety/performance data collection and incident reporting.
Preparation of clinical evaluations, PMCF study design and reports to demonstrate continued device performance and safety.
Assessment of publication obligations, preparation and publication of protocol and result data to registries and authorities.
Expertise Areas
- Clinical trial management
- Pharmacovigilance and safety reporting
- Digital pharmacovigilance and social-media screening
- Post-market surveillance and device vigilance (EU MDR)
Key Technologies
- ICH-GCP clinical trial standards
- ISO 14155 medical device clinical investigation standard
- EU MDR compliance, UDI and EUDAMED-related processes
- Pharmacovigilance case processing workflows and PV databases
News & Updates
In-house event announcement and meetup information for clinical research professionals.
Discussion of regulatory obligations for screening digital and social media channels and options for implementing digital monitoring with configurable delivery to PV workflows.
Overview of clinical evaluation requirements under EU MDR and offer to prepare and update clinical evaluations to demonstrate device benefit, performance and safety.
Description of PSUR purpose and offer to support sponsors/MAHs in preparation of comprehensive, concise and critical periodic safety reports.
Discussion of PMCF obligations under MDR and recommended PMCF activities for device manufacturers.
Analysis of MDR timeline changes and implications for manufacturers, including an outline of key MDR changes (UDI, EUDAMED, clinical evidence and PMS requirements).
In-house event announcement and meetup information for clinical research professionals.
Discussion of regulatory obligations for screening digital and social media channels and options for implementing digital monitoring with configurable delivery to PV workflows.
Overview of clinical evaluation requirements under EU MDR and offer to prepare and update clinical evaluations to demonstrate device benefit, performance and safety.
Description of PSUR purpose and offer to support sponsors/MAHs in preparation of comprehensive, concise and critical periodic safety reports.
Discussion of PMCF obligations under MDR and recommended PMCF activities for device manufacturers.
Analysis of MDR timeline changes and implications for manufacturers, including an outline of key MDR changes (UDI, EUDAMED, clinical evidence and PMS requirements).