Clinical Service

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Headline: 
Clinical Service
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SynapCon Ltd. offers its services to the pharmaceutical, biotech and medical device industries.

Our core competences are:

  • Trial design
  • Consultancy for the realization of clinical projects
  • Project management
  • Regulatory affairs (application and reports to authorities)
  • Quality management
  • Monitoring
  • CTMS EasyClin® 

Based on reliable co-operations with long-term international partners, we also implement:

  • Data management
  • Medical writing
  • Metrics development
  • Bio-statistical analysis
  • Pharmacovigilance
  • Complete drug support
Accordion: 

Project Management

Clients use our services for successful completion of complex clinical trials.
The eClinical solution EasyClin® allows our customers and us to keep an up-to-date overview of all trial processes. Our project management services include:

•    Study set-up, support with contract negotiations, investigator recruitment like site identification, selection and if required feasibility
•    Budgeting
•    Design of study documents (study protocol, CRF, contracts etc.)
•    Trial Master File set-up and maintenance
•    Overall planning and organization
•    Review of reports
•    Collaborations (Biometry, Medical Writing, Pharmacovigilance, Statistical Analysis, Drug Supply)

Study Monitoring

Benefit from our clinical monitors. They are well trained scientists, mostly multilingual and experienced in different indications. We offer this service in various countries. Our monitoring services include:

•    Start-up and initiation tasks (Assessment- and Initiation Visits)
•    Investigator Site File set-up and maintenance
•    SDV (Source Data Verification)
•    Reporting (comprehensive and timely visit reports)
•    Collection and maintenance of essential documents
•    Site management
•    Query resolution
•    Drug accountability

Quality Assurance

Take advantage of our quality management which is part of permanent review by internal and external specialists. In addition to our quality assurance procedures we provide the following services:

•    Co-Monitoring
•    SOP Management
•    CRO Evaluation

Regulatory Services

Our experienced team will be glad to support you through all regulatory affairs. This applies to national and local authorities as well as ethic authorities and all related tasks . We have passed regular Sponsor audits successfully.

Legal

Please contact our office for information regarding contract management and the function of a legal representative. This includes contract negotiations, subcontracting with hospitals and private practices.