Medical Products Supplies Companies

Al. Korfantego Wojciecha 83, 40-160 Katowice
Poland
Telephone +48 32 4799990
Fax +48 32 4799991
2kmm@2kmm.pl
http://2kmm.eu

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07 Medical Services and Publications
07.16 Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Certification and testing of medical devices, quality assurance
Clinical Research & Certification Services
2KMM CRO is a trusted provider of comprehensive services and solutions supporting management and execution of research projects for pharmaceutical industry, biotechnology, medical devices and healthcare. As a contract research organization 2KMM focuses on, and offers substantial expertise in:

eCRF design and development,
clinical data management,
biostatistics,
medical writing,
project management

for both, clinical trials as well as non-interventional studies.
Since 2005 2KMM has been conducting clinical/observational studies and running patients registries with the use of proprietary, cutting-edge electronic data capture eCRF platform named GoResearch™. Currently, during around 50 international and local studies, observation data of 50.000 patients from 14 countries has been collected by 3.300 investigators from 2.000 sites on
the GoResearch™.

Product category: Certification and testing of medical devices, quality assurance
GoResearch™ EDC
GoResearch™ is a fully validated, innovative internet platform for electronic data capture (EDC) created by
2KMM for research projects such as clinical/observational studies and patients registries. It offers a wide range of features supporting such projects in various areas such as:

data collection with the use of individually customized case report forms (eCRF) to meet the requirements of each study,
configuration of the information flow and the Adverse Events management procedures (including automatic e-mail notifications to safety departments),
random allocation to a treatment arm through the built-in randomization module,
real-time validation of the registered data (Edit Checks),
full tracking of data modifications (Audit Trail),
management of queries with an option of automatic query generation,
Source Data Verification (SDV),
ePRO, eSource and mHealth data integration through dedicated mobile and/or web applications or flexible application programming interface (API).

GoResearch™ meets all industry standards applicable to such systems, including FDA’s 21 CFR Part 11 regulatory requirements
and specific areas of GCP regarding electronic data.

Product category: Certification and testing of medical devices, quality assurance
GoProject™
GoProject™ is a validated multimodule software platform for project and quality management, integrating key processes of a modern,
quality driven organization. It offers a wide range of features to support organizations’ day-to-day activities in the following
areas:

project management with activity tracking,
Standard Operation Procedures (SOPs) management,
Learning Management System (LMS),
centralized personnel CV management.

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About Us

Company details
Where Life Sciences meet IT – CRO services and eClinical solutions with global reach.

For the last 15 years we have been providing the highest quality standards and effective support to our partners and their realization of clinical trials and observation studies.

Quality and security
Provision of the highest quality product by validating the process at every stage of its life cycle. Quality and data security confirmed by ISO 9001 and 27001 certificates and a set of internal SOP procedures.

Optimal solutions supporting business processes
Delivery of optimal quality and scope solutions through cooperation with an experienced, interdisciplinary team of professionals.

Newest technologies
Modern and effective IT tools enabling flexible adaptation to the specific project requirements.

Company data
Number of employees

20-49
Foundation

2003
Area of business

Information and Communication Technology
Medical Services and Publications

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