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Pharmaxi partnership existing partners

Certified partner
NoyMed LLC

NoyMed is a contract research organization (CRO) specializing in Biometrics services. We offer expert Biostatistics, Statistical Programming, CDISC Implementation, Data Migration, and Clinical Data Management services to pharmaceutical, biotechnology and medical device companies worldwide. We are an approved vendor for a huge number of pharmaceutical, biotech companies and CROs globally working on different outsourcing models.

Our team has more than 10 years of experience in almost all therapeutic areas and in various phases of clinical development. We have experience working with different EDC systems e.g Medidata Rave, OpenClinica, Medrio, Oracle InForm etc. We support studies from study startup to closeout preparing final FDA, EMA submission ready packages.

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Key information
Type: Small CRO
Country: Armenia, USA
Core activities:
  • Data Management
  • Biostatistics
  • Statistical Programming
Website: noymed.com
Prometheus Bio-Medical Inc

We are multinational CRO and covering Caucasus Region and particularly Georgia as the most desirable country to conduct Clinical Trial due to the fact that Georgia is well-known in the world where Approval to conduct Clinical Trial from the Ministry of Health’s Drug Approval Agency has maximum timeframe to issue Certificate of Approval within 21 days. However, as we have long term excellent relationship with the Regulatory Agency of the Georgia, in our experience we have had obtained Approval within two weeks.

Our Investigational Site network under our direct management have conducted numerous Clinical Trials and many of them have past FDA inspection with “Thank You” letters as there were no issues found and everything was in compliance with ICH/GCP.

Our company has Northern American headquarter in New York city (Manhattan) and European headquarters in the country of Georgia.

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Key information
Type: Small CRO
Country: Representation in Georgia, with main office registered at New York, USA
Core activities:
  • Obtain agency, where necessary, before studies begin
  • Select qualified investigators to conduct studies
  • Select qualified persons to monitor the conduct of studies
  • Adequately monitor clinical investigations
  • Maintain adequate records studies.
Website: prometheus.world
Aixial s.r.o.

Aixial is the CRO of ALTEN Group (www.alten.com), a large and profitable group with revenues in 2017 of 2 Billions € and 28 000 people worldwide.

Aixial is a full-services CRO with 4 main fields of expertise: Clinical Operations, Clinical Data Science, Vigilance, Regulatory Affairs.

Aixial’s strategy is to develop the long-term partnerships with its clients thanks to its quality of theservices and of its people and to be the alternative between Global CROs and Local CROs.

Some of the countries we provide the full clinical support are: France, Belgium, Switzerland, Germany, the Czech Republic, Slovakia.

Our clients deserve to work with the best talents with the best proactivity and reactivity, flexibility and transparence.

With 500 people in July 2018 and revenues of about 40M € in 2017, AIXIAL is among the Top 5 European CROs.

aixial
Key information
Type: Medium CRO
Country: Czech Republic, France
Core activities:
  • Biostatistics
  • Data Management
  • Clinical Operations
  • Monitoring
  • Pharmacovigilance
Website: aixial.com
Convex CRO

As a local contract research organization, we conduct multicenter and single center clinical studies within Bulgaria.

Our capabilities cover A – Z clinical research services starting from: feasibility assessment, study teams and sites selection, budget management, contracts negotiation, medical writing, regulatory activities, investigator meeting organization, study start-up support, study team training, project management, subjects recruitment, sites management, vendors management, clinical monitoring, safety reporting, auditing, data management, biostatistics, final report development and scientific consulting.

On the other hand, our privately-owned center for early phase human and drug research with a built-in phase I unit enables us to conduct a variety of single-center clinical research on healthy volunteers and specific patient populations:

  1. Phase I/II clinical studies
  2. Pharmacokinetic and Pharmacodynamic studies (PK/PD)
  3. Bioequivalence and Bioavailability studies (BE/BA)
  4. Safety and Efficacy studies
  5. Food Supplements studie
  6. Medical devices studies
  7. Vaccines studies
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Key information
Type: Small CRO
Country: Bulgaria
Core activities:
  • Medical writing
  • Regulatory and contracting process
  • Monitoring
  • Clinical operations
  • Biostatistics
Marti Farm Ltd.

Marti Farm Ltd., company based in Zagreb, Croatia is a contract research organization supporting the needs of the companies working within pharmaceuticals, biotechnology, medical devices, food supplements, cosmetics and healthcare industries across a variety of consulting and operational services.

Mart Farm Ltd.provides the following services:

  1. Clinical trials
  2. Pharmacovigilance
  3. Regulatory Affairs/Product Registration
  4. Medical Writing
  5. Reimbursement & Market Access
  6. Patient Support Programs
  7. Medical Information Service
  8. Translations
  9. eCTD
  10. Auditing

We are internationally recognized as a reliable partner and provider of consultancy and regulatory services with a proven track record of 9+ years. Our core belief is continuous personal development aimed at strengthening our expertise and approaches in order to drive added value for our clients from both the operational and the strategic aspects.

Over the last several years, we have been increasingly expanding our business internationally in search for new satisfied clients and trusted partners.

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Key information
Type: Small CRO
Country: Croatia
Core activities:
  • Clinical trials
  • Pharmacovigilance
  • Registration/Regulatory services
  • Medical Writing
  • Patient Support Programs
Website: martifarm.com
Bestat Pharmaservices Corp.

Being a leading contract research organization (CRO) in Taiwan, Bestat is dedicated to offer clinical services with the highest quality.

As experienced professionals within the industry, we provide customized services, which can be deployed on a stand-alone basis or as part of an integrated “comprehensive-service” solution, including:

  1. Trial design
  2. Regulatory compliance
  3. Data management
  4. Biostatistics
  5. Clinical operations
  6. Medical writing
  7. Auditing

Our teams always have the good professional spirit with highly efficiency and cooperated attitude. You can trust that we will be your good partner. So we are the best choice for you. Welcome to contact us if you are interested in Bestat.

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Key information
Type: Small CRO
Country: Taiwan
Core activities:
  • Project Management/Regulatory Affairs
  • Medical Affairs
  • Clinical Monitoring
  • Data Management
  • Statistical Analysis
Website: bestat.com.tw
Finklyn GmbH

Finklyn is a site payment provider that enables efficient invoice and payment management in clinical trials.

Our digital platform supports you in achieving your goals and regain focus on your core activities:

  1. Successfully administer site payments and manage invoices from any device at any time
  2. Save time and reduce risks related to accruals and reconciliation
  3. Automate financial workflows and mitigate invoice errors by linking EDC data
  4. Know where your study is heading. Finklyn transforms your ability to track, forecast and control site budgets
  5. Collaborate with your study partners and across your organization
finklyn_logo
Key information
Type: IT company
Country: Germany
Core activities:
  • Invoice management
  • Automated payments
  • Budget forecasting
Website: finklyn.com
CRFF-Solutions

CRFF-Solutions is a cooperation of companies active in clinical research, covering all areas of clinical drug development. Emerging from classical phase I units, the cooperation extended phase I activities from male and female healthy young and elderly volunteers to target or special patient populations to serve as pharmacological models investigating the impact of impaired organ function on absorption, distribution, metabolization and excretion of investigational compounds.

CRFF-Solutions gained also experience in a variety of interaction trials including PK/PD correlation.
An exceptional recruitment and trial team building system guarantees high recruitment and retentions rates. The innovative recruitment system allows also to perform proof of concept trials and assist in multi-center phase IIb and III trials as rescue site provider.

Emerging from a highly standardized phase I unit, CRFF-Solutions transferred its concept of controlled boundary conditions to hospital based clinical sites, specialized in different therapeutic areas, for phase II and III clinical trials.

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Key information
Type: Medium sized cooperation of SMOs and CROs with phase I units
Country: Germany
Core activities:
  • Phase I clinical trials in male and female young and elderly healthy subjects as well as in special populations (e.g. oncology patients, renal or hepatic impaired patients)
  • Phase I pharmacodynamic trials (e.g. TQT trials according to FDA standards in healthy subjects and risk populations (e.g. post-infarction patients)
  • Proof of concept trials in the target populations (phase IIa)
  • Clinical trial site selection and management for multi-center phase IIb and III trials
  • First experience in phase-less drug development by completing phase I and IIa activities in one protocol within less than six months
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