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PHARMNET, s.r.o.

Description: 

PHARMNET, s.r.o. is an independent CRO located in Prague, Czech Republic. Founded in 1994, it is currently conducting approximately 50 clinical studies in parallel each year. The PHARMNET team consists of office based physicians and doctorate level professionals with up to 20 years of experience in organizing Phase II-IV studies.

We maintain contacts with skilled Czech and Slovak investigators working in the following areas: general medicine, psychiatry, neurology, rheumatology, oncology, cardiology, transplantation medicine, gastroenterology, gynecology, respiratory diseases, urology, pediatrics, proctology, infectious diseases, hematology, vaccination, disorders of lipid metabolism, thromboembolic disorders, lipid disorder, ophthalmology. We have extensive experience in organizing long-term studies in chronic diseases.

Our intimate knowledge of local milieu allows us to establish an extensive network of investigators in any medical field in considerably short time and rescue projects suffering from slow recruitment rate.

International studies requiring extensive recruitment and/or coverage of specific European countries are organized jointly with the AcrossAlliance partners with the support of project management tools developed for that purpose and certified to ISO 9001:2008 by TÜV (Certificate No. 01 100 06 453/07). Our lead Project Managers are IPMA certified and use sophisticated internally developed software tools allowing a fast tracking of all study activities and keeping the audit trail.

Our services comprehend:

Protocol writing

CRF development

Project management

Regulatory submission

Qualified translation of study documents to Czech or Slovak

Study site selection

Investigator and hospital agreements negotiation and fees management

Investigators’ meeting organization

Clinical study monitoring, site initiation, site monitoring, close out visits

Clinical supplies accountability

Site audits, system audits and vendors audits

Compliance monitoring visits (in Czech, Slovak, English and Russian)

Medical writing (English, Czech)

e-CRF, DM, statistics (in collaboration with our AcrossAlliance partner: ICTA PM, Dijon, France)

We follow either the Client’s SOPs but we may also work under our own SOPs, compliant with the EU legislation. Our staff participates in continual training both in and outside the company.

Our client base are pharmaceutical and biotech companies seeking fast recruitment rate and outstanding quality at reasonable prices (mainly repeat customers), as well as foreign CROs seeking a task-specific support in Czechia or Slovakia.

Our comparative advantage can be summarized as follows:

a. Scientific methodology background of the management team qualifies the CRAs trained in Pharmnet to make decisions with a full awareness of reason and ultimate objective of each step in the study, assuring the integrity and reliability of the study data;

b. Pharmnet’s CRAs priority is detailed evaluation of source documents on site, assuring data integrity and valid reporting of all events in the study;

c. A sophisticated original ClinPoint® tool allowing fast electronic storage, tracking and cross-reference of study documents

d. Pharmnet’s training methods passing the "company memory" to all employees qualify the CRAs for providing advice and support to investigators in unexpected and atypical situations;

e. Project oriented approach with careful planning, risk assessment and tracking all key parameters of the study, allowing compliance to study procedures and an effective application of necessary corrective actions;

f. An ISO certified international project management system allowing smooth cooperation with Pan-European network of partners (Across-Alliance)

g. Flexibility and respect for Sponsor’s needs;

h. Experience-based knowledge of local milieu, including individual performance and reliability of investigators

i. Know-how in fraud prevention and detection.

Services: Audits, Clinical Study Monitoring, Compliance Monitoring Visits, Investigator Recruitment, Investigators’ Meetings, Project Management, Translations.

Services: 

Case Report Forms, Clinical Study Reports, Clinical Trial Monitoring, Contract Auditing, Data Management, GCP Compliance, Medical Devices/Combination Products, Medical Writing, Project Management, Protocol Development

Contact Information: 

PHARMNET, s.r.o.
Peckova 13
Prague 11, , 14900, CZE
Phone : 228414545
Fax : 228413204
Internet : www.pharmnet.cz
Email : pharmnet@pharmnet.cz
Contact Person : RNDr. Jan Malac, Ph.D.