Phase 1

Phase 0 (consisting of sub-optimal dosing PK and PD studies in man) and Phase I studies (primarily conducted for dose finding and safety) are where the clinical development phases begin.

The decision to move from pre-clinical development into clinical studies triggers a wealth of data analysis requirements and associated documentation demanding expertise from a number of diverse skill sets. Common documents to be created at this time include:

Effective Medical have a broad team of experienced individuals with skills in pre-clinical development (including toxicology and PK/PD) and the management and conduct of early clinical development programmes. We can provide advice and guidance on the requirements for all Phase 0/1 trials to ensure you get the most out of each study, and deliver the required documentation accordingly; as well as manage and deliver the process of regular updates as new data emerges.

Phase 2

Phase II studies are often the first time the target patient population receive promising medicines, and can be the first test of efficacy in addition to safety in these patients.

Many of the regulatory/clinical and pharmacovigilance deliverables are the same as those required in Phase 0/I, however there becomes a growing requirement to maintain core documentation with emerging data and as such, many of these deliverables (see Phase 0/I above) are re-addressed and updated throughout this phase.

Effective Medical will assist in ensuring new data is incorporated into deliverables quickly and accurately, minimising time and cost delays. Additionally, we can provide expert input on the big decisions that Phase II addresses, including whether to proceed in development. Services we can offer include:

Phase 3

Phase III takes you a step closer to marketing authorisation (MA) and a return on investment. As with previous phases, much of the documentation requirements in this phase remain the same; however as new data emerges and product development continues it is imperative the document deliverables remain updated with emerging information to ensure timely MA.

Effective Medical have a vast experience of creating regulatory consultation documentation building up to the marketing authorisation application and in creating robust and comprehensive high-quality submission packages for all major markets. After submission, Effective Medical also provide a full service to manage and respond to regulatory questions in a timely manner. Services include:

Phase 4

The focus of Phase IV is to ensure your continued presence in the market by delivering on any marketing authorisation commitments and ensuring ongoing post-marketing safety surveillance.

Effective Medical provide support for both bespoke programs of work (such as creating the documentation required for license renewals, POM-P-GSL switches or regulatory responses) or providing full post-marketing management services managing all your regulatory obligations from ADR reporting through to safety surveillance, product label management and regulatory reporting commitments (including PSURS/PBRERs, RMP creation and updates).