MedITEX  –  Medical  IT  Experts  

IVF  So,ware  
 
www.meditex-­‐so,ware.com  
 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:  

     
     
 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:  

 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?
 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
 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 “

 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
 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
 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)
 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
 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

 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
 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)
 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
 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
 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
The software
Workflow Management

NIS

LASER-Microscope

Evaluations and charts

Billing software

Scanner

Letters and reports

Additional data fields

Endolab
Material
Organizer
 Taylor-made functionality

My RecDate

Add-on

Add-on

Add-on
 Customizeable output
Statistics

Reports

Graphics
Partnership
Conformity

Support
by Development
local hero
 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