Clinical-operations-development

Clinical operations & development

AIXIAL offers pharmaceutical, biotech and medtech companies full coverage of Phase I-III and late phase clinical studies for drugs and medical devices in Western, Central and Eastern Europe through our European offices.

As a well-established high-quality European service provider, AIXIAL contributes to successfully bringing your products to the market in a unique one-stop shop approach for Europe as early, safely and cost effectively as possible.

AIXIAL

  • Conceives your development program and clinical protocol
  • Secures your regulatory submissions
  • Select the right investigators through in depth feasibility
  • Initiates and monitors the investigators
  • Shortens the patient recruitment time
  • Improves the patient retention ratio
  • Anticipates the risks and solve the issues
  • Provides high quality data and reports
  • Meets the Regulatory requirements

 
MAIN FIELDS OF EXPERTISE

  • Oncology
  • Central Nervous System (CNS) (eg Alzheimer, neurodegenerative diseases, multiple sclerosis, psychiatry)
  • Cardiovascular diseases and metabolism
  • Orphan drugs
  • Many others

 
TYPES OF PRODUCTS

  • Chemical drugs and bioproducts
  • Advanced therapy
  • Medical devices
  • Combination Products

 
SERVICES IN CLINICAL RESEARCH

  • Consulting
  • Phase I, II, III studies
  • Late Phase studies, Phase IV
  • Non-interventional studies and registries
  • Project management
  • Scientific and study Committee management
  • Regulatory Submissions
  • Monitoring
  • Clinical Monitoring
  • Data Management
  • eCRF
  • Statistics
  • Medical writing
  • Vigilance

 
GEOGRAPHICAL COVERAGE

  • Western Europe
  • Central Europe
  • Eastern Europe

FOR EACH STUDY, WE BUILD A DEDICATED CLINICAL TEAM

  • Central coordination: a Project Manager, Access Gate for the sponsor, assisted by a Study Assistant
  • CRAs: Pre study visit, Site selection, Investigator Training, Site Initiation Visits, Interim Monitoring visits, Site Management, Site Support, Close out visits
  • Study Technicians, Study nurses: Support to the center and investigators

SPECIAL FOCUS ON THE STUDY CRITICAL PHASES

  • Identification and Selection of the best recruiting investigators
  • Fast and reliable Feasibility studies to select the most appropriate countries and investigating sites
  • Regulatory Submissions phase
  • Initiation and validation of the sites to speed up the FPFV
  • Enrollment Phase optimization
  • Fast Management of the last queries and database lock

TRANSPARENCY WITH THE SPONSOR

  • Definition of a clear communication plan
  • Key Performance Indicators (KPI)
  • Periodic status reports
  • Periodic Lesson-Learned Meetings with the sponsor

Biometry

Highly-skilled team dedicated to your projects assuring you on fast and quality work. Our most experienced Data Managers, Programmers and [...]

Vigilance & medical information

AIXIAL offers pharmaceutical, biotechnology, medical device, nutritional and cosmetics companies full coverage for post-marketing vigilance and product safety in Phase [...]

Regulatory affairs

Preparation and submission of tender files to the relevant authorities Management of registration files: • Drafting of marketing authorization applications [...]

Quality assurance

Audits (investigator sites, CROs, PV System audit) Quality control of documents submitted to relevant authorities Drafting and revision of procedures [...]