Not sure if invivodata Consulting (formerly PRO Consulting) is right for you? Our services will help you answer these questions:

COA Strategy

Why include COAs in your medical product development program? Do you know what symptoms/concepts are the most important and relevant to your target patient population?

invivodata Consulting’s COA Strategy services will:

• Develop rationale and justification for incorporating COAs in medical product development programs
• Target your audience. Your COA strategy will be tailored for regulators, payers, the scientific community, and other target audiences
• Identify the relevant and important concepts for your research, and gather supporting evidence.
• Assemble a holistic strategy that includes evidence gathered from published literature, competitor’s labels, clinical experts/key opinion leaders (KOLs), observers, and – most importantly – patients.

Instrument Selection / Modification / Development

What is the most effective way to measure the symptoms/concepts that you have identified in your COA strategy? What available instruments will best meet your needs? Do instruments need to be modified to fit your strategy, your targeted concepts, and desired endpoints? If no instrument exists, do you need to develop new instruments that will meet regulators’ expectations?

invivodata Consulting’s Instrument Selection / Modification / Development will assist you in determining:

• How to identify and select instrument(s) that are most appropriate to support your COA strategy
• If an instrument(s) exists that – with modifications – could appropriately measure your targeted concepts. We will make those modifications in line with scientific and regulatory expectations
• If an instrument does not exist to best support your COA measurement strategy, we can create instruments to assess key concepts in a target population that meet scientific and regulatory expectations

Instrument Migration from Paper to Electronic Format

Are you migrating an instrument from paper to an electronic format? Are you confident that migration didn’t change any of the instruments’ properties and will comply with regulatory guidelines?

invivodata Consulting will assist you in:

• Determining what, if any, activities are necessary to demonstrate equivalence between the paper and migrated electronic format
• Determining the requirements for copyrighted instruments, including liaising with copyright holders and/or instrument developers
• Conducting equivalence activities (as needed), which may include a qualitative (cognitive interviewing) or a quantitative (equivalence) study.

Regulatory and Communication Support

Are you confident that your interactions with regulatory bodies on your COA strategy, instrument, and endpoint choices will be successful? Are there other key stakeholders, such as reimbursement groups or the scientific community that you need to communicate with regarding your COA strategy?

invivodata Consulting will assist you with the following items to support your regulatory interactions:

• Briefing books for regulatory agencies around the globe
• COA evidence dossiers for regulatory agencies across the globe
• Preparation for regulatory meeting attendance, including the development of key question and answer documents to assist in preparing teams for scheduled interactions
• Company’s regulatory strategy (development or evaluation)
• Electronic COA (ePRO, eClinRO, and/or eObsRO) regulatory inspection support
• Prepare for key communication activities (advisory boards/panels, etc.)
• Communicate evidence to scientific audiences (manuscript development, poster/podium presentations at scientific conferences)
• Communicate evidence to payers (demonstrate patient outcomes with COA data)