"Quality is never an accident,

It is always the result of intelligent effort."


John Ruskin


ABOUT ME


Hi, I'm Ella Raiser


My passion for the clinical research continues unabated even after more than 25 years, and I am pleased to be able to make a decisive contribution to data quality and patient safety with my expertise.


With my diverse qualifications in the GCP area and as EOQ Quality Auditor (ISO 9001) I support sponsors in clinical research studies for drugs and medical devices. 


I have served many organizations in different roles like Quality Assurance Manager, Auditor, Project Manager, SOP writer, Monitor and Lecturer.

PORTFOLIO


It's my mission to be a passionate, dedicated business partner with a focus on excellence to provide tailored research services to my customers.

Quality Services

Look beyond what’s expected.


- Systems/Process Audits for Drugs and Medical Devices
                  (Investigational Sites, CROs, Sponsors)

- Remote Audits (especially for Russia and Ukraine)

- Trial Master File Audit

- Quality Checks

- Root Cause Analysis & CAPA

- Peer Review

- QMS setup and maintenance

- SOP writing

- Interim Quality Assurance Manager


Project Management

Discover deep insights and better answers.


Planning, initiation, controlling and finalization of multicenter, international phase I-IV clinical studies including production planning and distribution of the investigational medicinal product.


Supporting Regulatory Affairs, submission to the Regulatory Authorities.

Monitoring

Let's do better, together.


Monitoring of Phase I - IV and Medical Devices Clinical Trials 


Co-Monitoring / Coaching and Training of Monitors


Available expertise in at least the following therapeutic areas:

Oncology, Immunology, Nutrition, Central Nervous System, Respiration, Volume Replacement, Organ Transplantation, Dermatology, Immunization, Gastroenterology, Narcotic Substances.

 

MDR-Studies: Renal Denervation, Deep Brain Stimulation, Back/Leg Pain

Training

Ready for today, prepared for tomorrow.


- Investigators and Study Teams including Study Nurse Trainings
- Clinical Monitor
- GCP and Regulatory/Ethical Requirements in Clinical Research
- SOP Training

- Communication Skills

 

Language: German, Russian or English

© Ella Raiser. Alle Rechte vorbehalten.

Vervielfältigung nur mit Genehmigung durch Ella Raiser.