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  • 1. MedITEX  –  Medical  IT  Experts  IVF  So,ware    www.meditex-­‐so,ware.com  
  • 2. Who  we  are?   CRITEX  GmbH      „CREATIVE  IT  EXPERTS“   Headquarter    in  Regensburg,  Germany   Distributors:  Russia,  Serbia,  Italy,  Canada,  Romania,  etc.   Founded  in  the  year  2000  for  individual  So>ware  Development  and  IT  ConsulDng     Specialized  on  IT  soluDons  for  doctors,  hospitals  and  laboratories  References:   Partner  Network:   Member  of:              
  • 3. What  is  MedITEX?   MedITEX  is  the  name  of  our  product´s  for  the  medical  branch.   e.g.   MedITEX  –  IVF    Electronic  documentaEon  for  IVF     MedITEX  –  Scheduler    Managing  appointments  and  paEent  scheduling   Product  website:    hRp://www.meditex-­‐so>ware.com  In  Germany  our  IVF  product  has  the  name:  
  • 4. What is data management good for?§  It keeps yourself occupied with documentation…§  It increases administration overhead…§  Only relevant for certifications (SOPs…)§  For driving lots of meaningless statistical evaluations… Really?
  • 5. What is data management good for?Data management is an essential part of quality management§  Streamline lab and clinical procedures§  Reach high and sustainable success rates§  Create individual approaches§  Deal with professional regulations and obligations§  Lower administration overhead§  Prerequisite for establishing excellence models
  • 6. Quality thinking!§  „We don’t have time...“ „We don’t have time not to “§  „Use intuition and common sense...“ „Collect and analyze data “§  „Poor quality results from people...“ „Defects come from processes “§  „Quality costs money...“ „Quality saves money “
  • 7. Foundation for quality§  Everyone in our organization is responsible for quality and for identifying and solving problems§  Quality must always be seen and rated from the viewpoint of the customer, where the customer may be external or internal§  Excellence relates to results – their effectiveness and reliability
  • 8. Quality system essentials§  Structural Quality –  Staff, devices, material, building structure§  Process Quality –  Diagnostic and therapeutic procedures, activities, interaction of teams§  Result Quality –  Precision, reliability and reproducibility of procedures and measurements, significance of values, success rates, patient experience
  • 9. Data management: How to?§  Definition of essential data to be documented –  Legal obligations (Germany: IVF register) –  Key variables (results, QM, administration, research etc.)§  Data entry –  Use of electronic databases recommended –  Entry with least possible delay –  Dedicate resources (personnel, time)§  Validation –  Data quantity (completeness) and quality (integrity, plausibility)§  Retrieval and evaluation –  Definition of essential / recurring queries –  Suitable tools –  Output formats (diagrams, tabs, statistical analysis)
  • 10. Defining data: Professional obligations§  e.g. German IVF-register –  Non-profit organization for quality assurance in human reproductive medicine –  Collects and evaluates treatment-related ART data –  Anynomized results are published annually –  Participation of IVF centers is due to the Medical Associations professional code of conduct binding –  Treatment data have to be submitted electronically via DIR´s proprietary DIR-DLL standard –  Defined field list for obligatory data, plausibility checks and checks for prospective data entry –  Certified software for data collection: •  DIR Pro (supplied by DIR) •  RecDate ADVANCE
  • 11. Defining data: Functional areasAdministration Consultation/ Endolab Cryolab Pregnancy and children Examination Patient data Anamnesis Endocrinology Cryobank Woman Woman Woman / Man Gyn / Andro Examination Woman Therapy Diagnosis Woman Planning Therapy Pregnancy Children Couple Couple and birth Diagnosis Man Examination Man Androlab Patient data Anamnesis Andrology Man Man Woman Man Couple Children Woman or man
  • 12. Defining data: Endpoint considerationsMaternal ageOvarian reserve Etiology SpermEtiology Paternal ageStimulation: Oocytes Embryos Pregnancy Delivery•  Protocol•  Strengths Maturity of eggs Method of Abortion•  Gonadotropins transfer Ectopic pr. Semen quality (type, dosage) and preparation Number Malformations•  GnRH A / Ant transferred Fertilization•  Monitoring Luteal support Culture conditions Cleavage
  • 13. Defining data: Detailing§  E.g. fertilization rates –  Sperm preparation –  Incubating conditions –  Insemination procedure (gas, temperature) –  Timeline –  Lab conditions (temperature, light) –  Preparation media –  Quality of semen and eggs –  Culture media –  Performance of lab staff –  Plasticware (vials, tips, dishes)
  • 14. Benefits from data management§  Improve clinical performance –  Monitor processes, main output factors (THBR, COS, OHSS)§  Streamline operations –  Workflow, patient administration, office services –  Data interchange (internal / external)§  Ensure conformity (EU-guidelines, registers) –  Certified documentation, plausibility checks§  Improve patients satisfaction –  Better clinical outcomes, individualized approaches
  • 15. MedITEX IVF§  In 2007, CRITEX developed a modern software platform for IT-based clinical documentation in Fertility§  The program conforms to the applicable professional and legal regulations –  Opportunity to document therapy cycles and export data according to German IVF-Register (DIR) –  Complies with EU guideline “Tissue & Cells”§  Allows comprehensive evaluations§  Includes individual options –  Customizable presets, optional data fields, add-ons§  Built-in data checks –  Plausibility & integrity of data
  • 16. Widespread usage§ Germany – 90 out of 120 ART centers use RecDate§ Russia – Operation of the national Registry “RAHR” – 80 out of 100 ART centers use MedITEX§ International – Installations in 15 countries – Translation in 7 different languages
  • 17. The software
  • 18. Workflow Management NIS LASER-Microscope Evaluations and charts Billing software Scanner Letters and reports Additional data fields Endolab Material Organizer
  • 19. Taylor-made functionality My RecDate Add-onAdd-on Add-on
  • 20. Customizeable output Statistics ReportsGraphics
  • 21. Partnership Conformity Support by Development local hero
  • 22. Thank  You!      Michael  Schindler      CEO                  E-­‐Mail:  michael.schindler@critex.de    Tel:  +49  941  5  99  39  33  9      post  address:    CRITEX  GmbH        member  of   Stobäusplatz  4   93047  Regensburg   Germany     Fax:  +49  941  5  99  39  33  3            product  website:  hDp://www.meditex-­‐so,ware.com