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Based on Sponsor's requirements, we prepare study design and assumptions, statistics considerations and budget for the study.
We also praticiapte in the process of protocol development or revision.
We cooperate with specialists such as Medical and Scientific Advisors, Statisticians, Data Managers and other required specialists.
We are dedicated to conduct clinical studies, including FIH (SAD, MAD), early phases (I-st, IIa, IIb) as well as IIIrd, IVth and observational studies. We re also experienced in observational studiec and studies with medical devices.
We have the possibility of hospitalization.
Based on our professional approach, we offer a set of services that meets the Sponsors’ needs starting from consultations at the earliest stage of the study (concept, design and study assumptions) up to final integrated clinical study report.
Before the beginning of each study, we conduct general and study-specific training for the study Team (i.e. investigators, nurses, laboratory technicians, coordinators and pharmacists). In order to popularize the knowledge and standards requirements typical for early phases.
We prepare study-specific medical, laboratory and pharmaceutical records (forms, logs, patients’ cards, instructions, manuals etc.).
We propose to conduct studies according to our procedures and study-specific manuals (pharmaceutical, laboratory, medical) which are always based on specific protocol requirements.
We lead an active recruitment amongst healthy people and patients so we have access to the wide population of Subjects.
Due to the own dedicated for recruitment website, we can influence on awareness about clinical trials amongst potential Subjects. Information about planned and ongoing studies as well as news and events concerning the site activities can be found on the website.
Our database of healthy volunteers and patients is improving, every day.
Statistics & Reports
We cooperate with Data Mangers and Statisticians, who participate in the protocol evoloution and analysis of final results from the study. We cal also provide statistics input to the study assumptions.
Our experts cooperate also with eCRF providers so to implement proper randomisation rules and procedures.
Both statistics and final reports are prepared by experienced medical writers (we can also propose verification of teh reports, if they are prepared by Sponsor's vendors)
Our goal is to cooperate only with expereienced and well-trained employees and co-workers. We organize internal trainings for our team (regular and study-related) as well as external trainings for our clients.
We also organize webinars, conferences and workshops.