Freelance CRA and projectmanagement.
Fase II through IV clinical trials.
Ethical submissions
Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout
Verifying that the investigator follows the approved protocol and all GCP procedures
Project management
Verifying that source data/documents and other trial records are accurate, complete, and maintained (SDV)
Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs.
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator
coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
Feasibility checks, locating and assessing the suitability of facilities at a study centre;
setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards;
training site staff to industry standards;
monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis;
writing visit reports; filing and collating trial documentation and reports.
ensuring all used and unused trial supplies are accounted for as a blinded of unblinded monitor.
closing down study centres on completion of the trial.
archiving study documentation and correspondence.
Company Details
- Employees
- 1
- Founded
- -
- Address
- Delftweg 172, Rotterdam,south Holland 3046 Nc,netherlands
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- cra2.nl
- Keywords
- for Renewable Energy.
- HQ
- Rotterdam , South Holland
Cra2 Questions
Cra2's website is cra2.nl
Cra2's LinkedIn profile is https://nl.linkedin.com/company/cra2
Cra2 has
1 employees.
View email and phone details for 1
employees at Cra2.
Cra2's industry is
Pharmaceutical Manufacturing
Cra2's top competitors are
Novatek Solutions,
Mpcprokim,
Guatecs Sas,
Global Engineering, Energy & Construction Geec,
Eprod Engineering,
Id Sarl,
Sines Tunisie,
Slama Frères,
Mpc Prokim Industrie,
Iqvia Nederland.
Cra2's categories are Pharmaceutical Manufacturing
Cra2's founding year is 2011
