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 Association's
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 areas
Administration 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 considerations
Maternal age
Ovarian reserve Etiology
Sperm
Etiology Paternal age
Stimulation:
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-on
Add-on
Add-on

20. Customizeable output
Statistics
Reports
Graphics

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