ARIANNE offers expert professional advice and know-how for execution of special projects. In order to facilitate international studies, ARIANNE provides sponsors support in the following:

Product Development

ARIANNE provides total product development integrated strategic planning

Consistent and continuous integrated strategic planning is the hallmark for product development success from early strategic consulting to full study management. Proven expertise in global operations allows us to execute and deliver projects on time and within budget.

  • Non-clinical strategic planning
  • Non-clinical study design and oversight
  • Selection, qualification and management of non-clinical contract research facilities for GLP and GMP studies
  • Scientific writing including non-clinical study reports and integrated summaries for regulatory filings
  • Clinical program strategic planning
  • Clinical operations management services
  • Clinical evaluation of product in-licensing opportunities
  • Development and execution of regulatory strategies for medical devices companies including IVDs (in vitro diagnostics) and combination products
  • Services and support ranging from trial design, pre-market submission and post-market compliance
  • International regulatory knowledge specific to the intricacies of the medical device and IVD industries

Regulatory

US and International Regulatory Affairs Services

ARIANNE can provide regulatory assistance for all types of products (small and large molecules, biologics and devices). We provide support for all phases of product development for the FDA and international regulatory agencies.

Regulatory Support Services:

  • Regulatory strategic planning
  • Liaise with regulatory agencies (e.g., FDA, Canadian, EU and Non EU, Asian agencies)
  • Global Sponsor Representation
  • Document preparation and submission for clinical studies (INDs, IND Amendments, CTAs)
  • Investigational medicinal products dossier (IMPDs), NDAs and BLAs preparation and submissions
  • Pre-market Submissions, IDE/510(k)/PMA
  • Electronic Submissions
  • Preparation and submission of orphan Drug Designation Applications
  • Submission and review of IRB approvals for clinical studies
  • Preparation and review of investigator’s brochure and updates
  • Safety report writing, safety monitoring and SAE reports
  • Preparation of annual regulatory reports
  • Regulatory Operations; Procedural Review and Audits

Analysis Plans

Concise, accurate reporting of study results begins with development of clear protocols and accurate, user-friendly case report forms. Our statisticians interact with sponsor scientists to develop a comprehensive statistical analysis plan, including:

  • Overview of study objectives
  • Description of study population
  • Sample size rationale and statistical power
  • Methodology for summary and analysis of demographic, baseline, efficacy and safety data
  • Description of statistical methodology

Biostatistics / Statistical Services

Statistical Analysis

Based on a well-developed analysis plan, statistical analysis implementation provides sponsors with timely, high-quality deliverables. ARIANNE biostatisticians are committed to your success starting with a well-thought and carefully designed analysis plan all the way through to the analysis of study data. We ensure complete, concise reporting, production of tables, listings and graphs in compliance with FDA and ICH guidelines.

  • Development of comprehensive methods reports that document planned and exploratory analyses
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results

Analysis Plans

Concise, accurate reporting of study results begins with development of clear protocols and accurate, user-friendly case report forms. Our statisticians interact with sponsor scientists to develop a comprehensive statistical analysis plan, including:

  • Overview of study objectives
  • Description of study population
  • Sample size rationale and statistical power
  • Methodology for summary and analysis of demographic, baseline, efficacy and safety data
  • Description of statistical methodology
  • Shells of all planned tables, listings and graphs

In addition to providing expert statistical support for individual studies and programs, our statisticians provide consultative statistical support, including:

  • Program development advice
  • Statistical methodology review
  • Analysis interpretation
  • Report review
  • Presentation to regulatory authorities
  • Data Safety Monitoring Board (DSMB) participation
  • Preparation of annual regulatory reports

QA Services

Conducting audits early in the clinical stages of development identifies systematic problems with the conduct of your study, such as misinterpretation of protocols. These audits enable early intervention and corrective action to avoid preventable delays and expense in the conduct of your program.

  • Our auditors have expertise in indigenous country requirements as well as FDA/ICH clinical research requirements.
  • Our QA personnel are accustomed to working as a team with your organization. At no additional cost to clients, we share information on mutually agreed audit plans and discuss QA and compliance issues with you.

We offer:

  • Individual site audits
  • Document audits
  • Internal system audits — audits of SOPs, documents and staff training for improvement of efficiency and compliance
  • Investigator-directed audits — investigation of questionable data for clients
  • Team members have hands-on experience in FDA audits
  • Vendor audits of subcontractors, such as central lab, investigational study materials
  • QA consulting
  • We can provide independent auditors when requested

Education

ARIANNE has a complete education system available for small companies looking to expand on training in Regulatory and Clinical compliance. We can also supply annual training on standard operating procedures and updating your company as needed. Contact us for more information at: info@ariannecorp.com

Additional Services

ARIANNE offers additional services to facilitate international studies, ARIANNE also provides sponsors support in the following:

  • Feasibility studies and patient access planning
  • Document translation
  • Import/Export licenses
  • Local Insurances
  • Drug Depots
  • Identification of independent third parties for radiology and/or laboratory centers