What We Do

Services

AlcheraBio is a comprehensive resource supporting many aspects of the animal health industry. We have provided a variety of services for animal health companies, biotechnology and life sciences companies, and investors since our inception in April 2001.

Pivotal Clinical Trials (conducted under Good Clinical Practices, GCP)

Activities in support of GCP studies include:

  • Helping Sponsors design a development plan and negotiate the plan with the CVM.
  • Developing or assisting with development of protocols and case report forms
  • Preparing and producing Investigator manuals, casebooks, owner diaries and supporting materials
  • Developing study specific SOPs (Standard Operating Procedures) in consultation with the Sponsor
  • Identifying, qualifying, and training investigators
  • Monitoring and project-managing the trial
  • Managing clinical trial material (test article)
  • Reporting and managing adverse events
  • Data management
  • Statistical services
  • Quality Control and Quality Assurance services
  • Writing Final Reports
  • Coordinating the regulatory submission process, including pagination, copying, assembling and shipping
  • Writing and editing the FOI summary and proposed label language
  • Communicating and negotiating with the FDA Center for Veterinary Medicine

  • To request more information on AlcheraBio’s Contract Research services in the area of GCP trials, please click here.

Post-Marketing Studies

Post-marketing studies are undertaken after a veterinary product is approved for commercial use to enable an animal health company to introduce an approved product to the veterinary community, expand the use of a product among a given veterinary segment, or compare one approved product with another for the same indication(s). AlcheraBio is proud to have set the industry standard for post-marketing studies when we managed a 1000-dog study in support of PREVICOX® (firocoxib, Merial), completed in 2005.

Activities in support of post-marketing studies include:

  • Developing protocols and case report forms
  • Developing study-specific SOPs (Standard Operating Procedures) in consultation with the Sponsor
  • Identifying, qualifying, and training investigators
  • Identifying Key Opinion Leaders
  • Preparing and producing investigator manuals, casebooks, owner diaries and supporting materials
  • Managing investigator and owner reimbursement
  • Data management including developing the study database and entering study data and developing and maintaining study files
  • Managing the study
  • Reporting on the study, including assisting with study-related publications and other deliverables

    To request more information on AlcheraBio’s Contract Research services in the area of post-marketing studies, please click here.

Regulatory Affairs

Regulatory affairs include working with the Center for Veterinary Medicine at the Food and Drug Administration (FDA/CVM), Environmental Protection Agency (EPA) and the United States Department of Agriculture (USDA). Activities include:

  • Developing regulatory strategies, plans, and timing
  • Conducting or assisting with pre-development meetings with regulators
  • Liaising with regulators as a project moves forward
  • Preparing and submitting background for meetings
  • Drafting protocols based on regulatory requirements
  • Negotiating and resolving regulatory issues
  • Preparing presentations and attending meetings with regulators
  • Reviewing Chemistry, Manufacturing, and Controls (CMC) plans and helping prepare CMC submissions
  • Serving as US agent for ex-US companies bringing their products to the US for regulatory approval

    To request more information on AlcheraBio’s Regulatory Affairs services, please click here.

Other Services

Regulatory affairs include working with the Center for Veterinary Medicine at the Food and Drug Administration (FDA/CVM), Environmental Protection Agency (EPA) and the United States Department of Agriculture (USDA). Activities include:

  • Developing regulatory strategies, plans, and timing
  • Conducting or assisting with pre-development meetings with regulators
  • Liaising with regulators as a project moves forward
  • Preparing and submitting background for meetings
  • Drafting protocols based on regulatory requirements
  • Negotiating and resolving regulatory issues
  • Preparing presentations and attending meetings with regulators
  • Reviewing Chemistry, Manufacturing, and Controls (CMC) plans and helping prepare CMC submissions
  • Serving as US agent for ex-US companies bringing their products to the US for regulatory approval

    To request more information on AlcheraBio’s Regulatory Affairs services, please click here.