TRANSFORM your organization in an AGILE, MINDFUL, TRUSTWORTHY and LEARNING workplace
IMPROVE your organization’s POSITIVE PRACTICES and achieve BETTER PROFITABILITY
INCREASE JOB SATISFACTION of your Leaders, Managers and Employees
DISCOVER POSITIVE ENERGY SOURCES in your organization, that BOOST CREATIVITY and INNOVATIVENESS
Clinical Study Report authoring & support
We support you by:
Ensuring prompt delivery of high quality CSR.
Identifying a list of necessary documents to provide to Medical Writers thus helping them in preparing well-structured and well-written.
document, which supports your clinical development program, regulatory submission process, and ultimately drug labelling.
Preparation of ‘fit for purpose’ document which fulfils reporting requirements and facilitate FDA, EMEA and local regulatory review.
Clear identification of all members of the team confirming their roles, responsibilities and commitment to making their contribution to the CSR.
Presenting clinical study results within CSR according to the context of your current drug development program.
Interaction with the project team to provide a wider strategic understanding of the product and obtain key insights into specific aspects of the CSR such as statistical and pharmacokinetic interpretation.