Growing demand from regulators and other key stakeholders for Clinical Outcome Assessment (COA) data has nudged invivodata into an organisational reshuffle that the company says will better equip it to address the needs of its customers.
The US-based company, which supplies device-based eDiaries and other data-collection tools to the biopharmaceutical and medical device industries for use in clinical trials, is integrating its consulting division – formerly known as PRO Consulting – into its portfolio of Clinical Outcome Assessment consulting services.
The new, consolidated service, to be called invivodata Consulting, will both complement and integrate with invivodata’s eSolutions and regulatory services, the company notes. It can offer either a fully integrated set of COA services across the product lifecycle or selected services to meet a research team’s specific objectives.
FDA wants COA
The US Food and Drug Administration (FDA) has made it clear, invivodata points out, that clinical research must take into account all forms of COA, including patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs) and observer-reported outcomes (ObsROs).
“Our COA consulting services have been widely adopted in the biopharmaceutical and medical device community, as researchers increasingly seek scientific and regulatory expertise in developing, executing and justifying their COA strategies to regulators and other stakeholders,” commented Doug Engfer, president and chief executive officer of invivodata.
“Now our clients will interact with one organisation, regardless of whether their needs centre around critical pre-study consulting work, proven eSolutions for COA data capture in clinical trials or, as in many cases, both.”
In line with these changes, invivodata is launching a new corporate website that collates information on current global regulations relating to COA research, successful COA data-collection strategies as well as implementation case-studies, and on invivodata eSolutions and/or consulting services that can help clients meet their development, labelling and commercialisation goals.
invivodata is a privately held company with global headquarters in Pittsburgh, Pennsylvania, European headquarters in London, UK and a technology development centre in ScottsValley, California.