METHODS
We transform your IDEAS step by step to your PUBLICATIONS
Step1 Feasability
MedSciCare supports you to determine if appropriate resources (patient population, personnel, financial, and regulatory requirements) are available for a successfull completion of a trial. If required, clinicians and sponsors can be connected with each other.
We can support you with
- assessing feasibility of investigational sites regarding personnel and infrastructure
- calculating required study participants
- estimating costs to finance your project
- establishing contingency plans
- finding funding opportunities
- regulatory requirements
- registrating a trial
- writing an agreement between investigator and sponsor
Step2 Study design set-up
MedSciCare supports you in all stages essential before the study can be started.
Count on our professional support when it comes to
- strategic planning of the clinical trial
- a specific scientific question you need reliably answered
- setting up a study proposal
- the submission to the ethics/institutional review board.
- setting up a clinical study protocol
- setting a proper study aim
- setting a proper study hypothesis
- sample size calculation
- randomization
- setting up proper patient information
- setting up proper patient informed consent
- setting up proper case report forms (CRF)
- creating trial-related documents
- establishing a data base
- finding a study assistant
- finding a study monitor
- registrating the study
- statistical analysis plans
- managing and setting up national and international multicenter trials
Step3 Study implementation
MedSciCare supports you from the beginning to the end of the non-pharmaceutical clinical trial.
Our support includes
- trainings of study assistants and investigators
- help with data collection, entry, and source data verification
- study protocol modifications
- the assistance to meet regulatory requirements (e.g. adverse event reporting; safety reports)
- any scientific question regarding the ongoing trial that needs to be reliably answered
Step4 Data management
MedSciCare successfully supports you when it comes to data management after data collection.
Benefit from our long-term expertise when it comes to
- data capturing
- data import and export
- data extraction
- dealing with missing values
- data preparation for statistical analyses
Step5 Data evaluation
MedSciCare especially supports you with data analysis and easy to understand statistical consulting.
Find help regarding
- data review and simplification
- handling missing values
- statistical analysis
- scientifically sound interpretation and reporting of results
Step6 Publication edition
MedSciCare supports you with the preparation of any scientific text.
We offer support for scientific publications (e.g. papers, manuscripts, abstracts, posters, lectures,…) regarding
- editing to enhance comprehensibility
- translation from German to English
- formating according to journals’ requirements
- citation and bibliography
