Our team of project managers, regulatory experts and statisticians can offer the following support:

• Preparing a statistical analysis plan and drafting the corresponding section of the study protocol

• Assistance in drafting and reviewing all study documents

• Creating awareness of patient and public involvement (PPI): phrasing of PPI plans when applying for funding, assistance with carrying out PPI activities

• Setting up and maintenance of trial master file (TMF) and investigator site files (ISF)

• Submitting initial files or amendments to ethics committees, Swissmedic and other authorities

• Carrying out study registration, e.g. on clinicaltrials.gov

• Supporting contract management: drafting Data Transfer Agreements, Material Transfer agreements, and Clinical Trial agreements

Our team of quality managers, monitoring experts and data managers can offer the following support:

• Establish a quality management system (QMS) tailored to your requirements

• Develop, implement and maintain standard operating procedures (SOPs)

• Monitoring activities: creating a monitoring plan, monitoring local IITs, training potential monitors

• Centralized data monitoring: automated reports for the study team to ensure completeness of database.

Our team of data managers and data scientists can offer the following support:

• “REDCap full service”: we create a customized database tailored to your project needs.

• “REDCap light plus service”: we provide you with a database template and ongoing guidance throughout the time that you create your own database.

• Assistance in automated data collection from sources like data warehouses (DWH)

• Establishing randomization

• User management tasks such as account and center setup and role definition

• Centralized data monitoring

Our team of biostatisticians can offer the following support:

• Protocol development (Statistical methods)

• Sample size calculation

• Consistency check after data transfer

• Writing of a statistical analysis plan

• Data analysis based on SAP

• Visualisation of results

• Formulation of key findings

• Scientific publication/report and support for review process

Our native English speaker and expert in medical writing can offer the following support:

• Manuscript preparation: depending on your needs we offer:

o Proofreading: Correcting grammar, spelling, punctuation, syntax, and other language errors.

o Copyediting: Improving clarity, consistency, flow, style, and compliance with journal guidelines.

o Reviewing (pre-submission): Providing qualitative feedback on manuscript before journal submission, including structure, scientific argumentation, logical flow, completeness, and readability.

• Journal submission and resubmission support:

o Preparing and formatting manuscripts for submission.

o Assisting with manuscript submission through the journal’s submission system.

o Reformatting manuscripts for submission to another journal, if required.

• Revision support:

o Assisting with the preparation of revisions and point-by-point responses to reviewers after peer review

• Scientific communication:

o Preparing graphical abstracts, presentation slides, visual abstracts, and social media material to communicate research findings.

• Teaching:

o How to write a scientific paper