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MariaK is a consultancy providing services in clinical research and clinical trials management (phase I-IV) according to ICH-GCP guideline and to local laws and local requirements.
MariaK has many years of experience from pharmaceutical companies and CRO (Contract Research Organisation) in managing national and international Phase I to Phase IV clinical trials, all the way from the study start to the final clinical study report; including study outline, planning, coordination, management, performance, termination and reporting of the trials.
MariaK has experience in Clinical Project Leading in clinical trials having an overall administrative responsibility to supervise, co-ordinate and lead study specific activities and to implement and conduct a clinical study in accordance with the Company SOP´s, ICH-GCP requirements and local regulations.
MariaK has experience in Clinical Trial Management for Phase I and Phase II studies and offers pre-study services such as study protocol writing, CRF design, Data Management duties, study report writing and coordination and management of study team, setting up study documentation, also including SOP:s, and budget responsibility for clinical trials and consultants.