Mitglieds-Button des Unternehmerverband Landkreis Miesbach e.V.

Our services

A big network of Clinical Research Professionals (D, A, CH, NL, BL, F) facilitate comprehensive support for your study project and cops multiple indicators of drug trials, Medical Device- and Non- Interventional studies. The performance comprises:

  • Monitoring Support through an extensive network of quickly available, experienced CRA’s
  • Monitoring of clinical studies from Phase I till IV in all indication areas after GCP and ICH
  • Pharmaceutical studies
  • Medical-technical studies
  • Non-interventional studies
  • Medical and scientific planning of the study
  • Development of project planning, determination of a collective
  • Determination of Responsibility Split
  • Planning of logistics (samples, IMP, etc.)
  • Obtaining and evaluation of cost offers (CRO / other serviceproviders)
  • Vendor-Assessment pursuant ICH GCP
  • Preparation and review of test plan
  • Preparation, translation and review of patient information and consent form
  • Creation of other study materials (e.g. patient ID card, smock bags info)
  • Creation of other manuals (Labor-Manual, etc.)
  • obtaining, tracking, review and approval of Site Essential Documents
  • creation of advertising tactics with help from the media center of the University of Bonn and the university hospital
  • Coordination and control of all functional units of the study (incl. Monitoring/ Safety-Management/ Data Management/ ext. service providers, CRO /pharmacy etc.)
  • Coordination of project communication and control of project running (and others as to SOPs, GCP and deadlines)
  • Analysis of project status; development of status reports
  • Coordination of study medication
  • Practical execution of randomization
  • Budget supervision
  • Regular contact with testing center (telephone, e-mail, fax)
  • Transport of study materials
  • Installation and care of Trial Master File (TMF)
  • Preparation of Investigator Site File (ISF), incl. instruction
  • Creation of study specific logs, forms etc.
  • Support contract management:
    • adoption of sponsor function
    • with money lender study
    • with testing center
    • with service providers (CRO, labor, pharmacy)
  • Execution of insurances (clinical trials insurances, way-to- work accident insurances)
  • Communication with insurances during the study progress
  • Execution of feasibility
  • Development of questionnaires
  • First contact to the center
  • Arrangement of confidentiality
  • Traceability of documentation
  • Communication with the sponsor, Evaluation of feasibility
  • Filing at authorities/ ethics committee (preparation, performance, processing of defects) at:
    • Higher federal authorities (BOB (BfArM, PEI, BfS)
    • Responsible ethics committee
    • Involved ethics committee(s)
  • Authority submission according to § 67
  • Display at the local medicines commission
  • processing Amendment (changes of documents; approval procedures EK and BOB; display according to §67; updating the documents of the center)
  • Sign out of the study at EK, BOB and regional authorities
  • CRF development and review (incl. creation of CRF-fill in instruction)
  • Test with CRFs with trial patients for plausibility (Dummy Patients)
  • Compilation of CRF-folders
  • Creation of a patient diary
  • Questionnaires (obtaining licenses)
  • Creation of Data-Management Strategy
  • creation of study documents as Data Management Plan (DMP) and Data Validation Plan
  • TMF-care
  • CRF-Tracking
  • Study execution paper based (DDE) and electronic (EDC) inserted Clinical Data Management Systems:
    • XClinical MARVIN (EDC and DDE)
    • RedCAP (only DDE with non-AMG/non- MPG Studies)
  • In-house Data collection (DDE) database Set-Up and Validation
  • Query preparation and Query management
  • Coding (Coding AEs according to MedDRA)
  • Data import Data export creation of reports
  • User-Administration (Service) EDC
  • IWRS (interactive web response system)
  • Database-Reconciliation
  • CP-Audits
  • Vendor-Assessments
  • Planning of quality control in study projects
  • Biometric planning and design of the study
  • Planning of number of cases
  • Creation of „biometric“ parts of the study protocol
  • Creation and review Statistical Analysis Plan
  • Collaboration in DSMBs
  • Development of randomization plans
  • Planning and execution of interim evaluation
  • Statistic evaluation
  • Development of a biometric final report

Our previous customers