FNP

CLINICAL

Contract Research Organization offering comprehensive set of services for Phase I-IV clinical trials in Russia, where patient recruitment is typically extremely rapid and quality meets the highest international standards.

 

FORMULA FOR NOVEL PHARMACEUTICALS

 

ABOUT

 

FNP Clinical is a Contract Research Organization that was born in response to the growing number of clinical research projects initiated or planned by Russian pharmaceutical and biotech companies. The company was founded in 2012 by clinical research professionals with extensive experience in clinical trials as well as the unique experience gained by founding and developing several successful companies in Russia and the US (including two CROs). FNP Clinical was created to support the success of our clients with our experience and passion for excellence in clinical research. Partnership with FNP Clinical will streamline the clinical trials process and ensure that the highest quality study is completed in the timeliest manner possible.

 
OUR PRINCIPLES

Integrity in our dealings with clients, employees, partners and vendors. We believe that all relationships involved in a clinical trial require the utmost transparency, trust and respect.

Commitment to each client and their studies. We believe that each study that we undertake deserves to be treated as “first priority” and given full attention through all steps.

Quality of data. Clearly, in clinical trials, the data quality is critical. This is an aspect of our services that we pride ourselves upon, and which derives in large part from the experience and skill of our personnel and our belief that they are our most valuable assets.

OUR STRENGTH

Twenty-first-century Russia is set to become a new land of opportunity in biomedical research supported by a tradition of strong science, multi-billion dollar governmental programs, and modern hospitals. In addition, centralized medical care system in Russia remaining unchanged in decades allows rapid recruitment and strong retention of patients in clinical trials, which is critical for the overall quality and timeliness of studies. At the same time, as for any rapidly growing area, drug development in Russia has many pitfalls that remain to be resolved. These include a lack of uniformity in the technical capabilities of different study centers, differences in treatment approaches, delayed appearance of innovations, and logistical obstacles in some regions of Russia. Additional challenges come from regulatory authorities, where a shift to world practices produced a new set of rules and regulations. Given the circumstances described above, the choice of CRO partner may make the difference between completion of a successful, efficient, and high quality study and failure. FNP Clinical has the experience, skill, and commitment to be the right partner for your study.

 

CEO Welcome letter

FNP CLINICAL – Your Guide in the Field of Clinical Trials.

Welcome to the web site of FNP Clinical, a Contract Research Organization (CRO) offering a full package of services surrounding organization and performance of human clinical trials of all levels and phases.

We believe that our highly skilled and committed personnel are our strength so we are devoted to investing in their further development. Every aspect of each clinical trial is performed in accordance with the requirements of regulatory authorities, standard operation procedures, and agreed liabilities.

Our clients benefit from the dedication of an integrated team of professionals with strong expertise in the management and execution of international and local clinical trials. This team will ensure that quality is delivered at every time from planning to data reporting. FNP Clinical provides thoughtful attention to the needs of clients, intelligent involvement in their studies, experience that is both broad and strong, and access to a wide geographical spread of investigational sites.

FNP Clinical hopes to partner with you in bringing new drugs and therapies to market with innovation and speed. Thank you for your interest in our activities!

Sincerely,
Dr. D. Prudnikov

SERVICES

MEDICAL WRITING 

 

  • clinical development program for investigational product

  • study design/protocol synopsis

  • study protocol and protocol amendments

  • investigator brochure

  • patient information leaflet, consent, diary

  • clinical study report

  • scientific publications based on study results

  • case report form

REGULATORY SUPPORT
  • insurance for clinical study conduct

  • clinical study dossier preparation for regulatory authorities approval

  • import license for investigational product

  • export license for biological samples

  • regular reporting to EC and RA of study status updates and safety updates

VENDOR'S SELECTION AND MANAGEMENT AND AUDIT

 

Project and Site Management 

 

  • site feasibility, assessment, qualification and selection

  • site contracts negotiation / execution

  • study start up

  • investigators’ meeting preparation and conduct

  • investigators and CRAs study specific training

  • project management and monitoring plan preparation

  • site monitoring

  • site close out

  • safety monitoring and safety reporting during the study

  • organization and management of Phase I studies (First-in-Humans and BE)

QUALITY ASSURANCE AND QUALITY CONTROL

 

  • SOP creation and regular update

  • site staff [initial and regular update] trainings on GCP, regulations for clinical trials

  • site preparation for sponsor audits and regulatory inspections

  • site audit

  • CRO audit

 
 
 

TEAM

FNP Clinical employs a committed team with extensive experience and deep knowledge of all stages of clinical drug development: from analysis of pre-clinical data to planning First-in-human trial and then to even the most complex clinical trials. The founders of FNP Clinical have well-established reputations for professionalism and integrity in industry.

  

DMITRIY

PRUDNIKOV, MD

Chief Executive Officer

 

Dmitry Prudnikov is a co-founder of FNP Clinical. Before founding FNP, he has held management positions at Janssen Pharmaceutica and in several CROs:

  • Prudentas (now Atlant Clinical)

  • ClinStar (now PRA Health Sciences)

  • InnoPharm (now PPD Smolensk)

Dr. Prudnikov has been a practicing physician (anesthesiologist) and sub-investigator in the past.

EKATERINA NIKOLAEVSKAYA, MS

Chief Operating Officer

 

Ekaterina Nikolaevskaya is a co-founder of FNP Clinical. Before founding FNP she has held management positions at two CROs (Prudentas and ClinStar). Before clinical research she worked in the laboratory of genetic engineering.

Dr. Denis Chigir,

MD, PhD

Medical Director

 

Denis Chigir joined FNP Clinical in 2014. Previously Dr. Chigir worked as Medical Director at pharmaceutical company “Pharm-Sintez”, before that he was Project manager at two CROs (Prudentas and ClinStar). Before clinical research – Practicing Physician in neurology

CONTACT

FNP

Clinical

OUR ADDRESS

FNP Clinical LLC

Address: 5, 2nd Brestskaia, 123056, Moscow, Russia

Email:  info@fnp-clinical.com
Tel:  +7 (495) 646-13-87

 

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© 2019 by FNP CLINICAL.