Regulatory consulting case studies

Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. ICON’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.

A large pharma company submitted a New Drug Application for a targeted therapy treating a rare tumour subtype. To support safe use, a companion diagnostic PMA was filed in parallel with the FDA’s CDRH.

A Europe-based biotech preparing for a phase 1/2a oncology trial turned to ICON for support during their first IND submission. With limited FDA experience, they relied on ICON to navigate the 30-day review period and respond quickly to agency requests.

An international biopharmaceutical company based in the EU contracted ICON to support a new biologic drug application in Canada for an anti-cancer therapy for diffuse large B-cell lymphoma (DLBCL) under advance consideration.

A medical device developer faced clinical evaluation timeline delays due to under-enrolment. Discover how the collaborative partnership between the sponsor and ICON’s Medical Device & Diagnostics Research team steered the study from patient enrolment to FDA submission and approval.

ICON stepped in when a biopharma company required urgent rescue assistance with two phase 3 trials for Hidradenitis Suppurativa (HS) and Psoriatic Arthritis (PsA).

RIM System Configuration and Data Assessment is pivotal in regulatory business planning. It also helps in organising product registration process to track and manage all regulatory activities.

Software companies are incentivised to implement their solutions as quickly as possible, often leaving clients in a situation where the regulatory technology does not support the business process.

Software companies are incentivised to implement their solutions as quickly as possible, often leaving their clients in a situation where the technology doesn’t support the business process, users are frustrated, and return on investment is questionable.

The client received an audit finding relating to the insufficient tracking of investigational and post-approval commitments. Although investigational and post-approval commitments were previously out of scope for the RIM system dataset, ICON determined to increase the dataset scope within the RIM system to track commitments.

Various regulatory agencies, such as the European Commission, the EMA and national Head of Medicines
Agencies (HMA) have all published new recommendations on how to manage clinical trials in the wake of the coronavirus disease (COVID-19) pandemic.

ICON’s Regulatory Project Managers (RPMs) were approached by a client to deliver, in parallel, an initial US Biologics License Application (BLA) and an EU Marketing Authorisation Application (MAA) Major Amendment for a new formulation within an existing program.