meditex ivf product presentation
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www.meditex-‐so,ware.com
MedITEX – Medical IT Experts
IVF So,ware
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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:
Who we are?
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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 MedITEX?
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§ 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?
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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
What is data management good for?
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§ „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 “
Quality thinking!
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§ 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
Foundation for quality
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§ 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
Quality system essentials
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§ 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)
Data management: How to?
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§ 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: Professional obligations
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Androlab
Therapy
Cryolab Pregnancy and children Endolab Consultation/ Examination
Administration
Anamnesis Man
Examination Woman
Examination Man
Diagnosis Man
Diagnosis Woman
Planning Couple Therapy
Couple Pregnancy and birth
Cryobank Gyn / Andro
Children
Patient data Woman
Patient data Man
Anamnesis Woman
Andrology
Endocrinology Woman / Man
Woman Man Couple Children Woman or man
Defining data: Functional areas
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Pregnancy Delivery Embryos Oocytes
Sperm
Maturity of eggs Semen quality and preparation Fertilization Culture conditions Cleavage
Method of transfer Number transferred Luteal support
Abortion Ectopic pr. Malformations
Etiology Paternal age
Maternal age Ovarian reserve Etiology Stimulation: • Protocol • Strengths • Gonadotropins
(type, dosage) • GnRH A / Ant • Monitoring
Defining data: Endpoint considerations
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§ E.g. fertilization rates
– Sperm preparation – Insemination procedure – Timeline – Preparation media – Culture media – Plasticware
(vials, tips, dishes)
– Incubating conditions (gas, temperature)
– Lab conditions (temperature, light) – Quality of semen and eggs – Performance of lab staff
Defining data: Detailing
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§ 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
Benefits from data management
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§ 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
MedITEX IVF
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§ 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
Widespread usage
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The software
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Billing software
LASER-Microscope
Scanner
Additional data fields
Evaluations and charts
Endolab Material
Letters and reports
Organizer
NIS
Workflow Management
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My RecDate
Add-on
Add-on
Add-on
Taylor-made functionality
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Statistics
Reports
Graphics
Customizeable output
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Development
Support
by local hero
Conformity
Partnership
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Michael Schindler CEO E-‐Mail: [email protected] 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
Thank You!