During the first steps of clinical development stage, preliminary data consolidation and aggregation become fundamental to ensure an appropriate safety and efficacy profiling that best validates a pharmaceutical to proceed. Particularly for early clinical phases (Phase I and II) transferring all generated pre-clinical information to the clinical setting represents a big challenge.
Additionally, development requires to escalate the conclusions to larger, representative populations. These late phases of development are especially subjected to a highly complex regulatory context as the development approaches potential product registration and commercialization.
In order to guarantee success, the exact scope, timing and depth of clinical development plan must be strategically analyzed involving local regulatory authorities and stakeholders to ensure enough evidence generation according to regulatory requirements.
All this activity generates a strategic workflow of contacts, specific meetings as well as data and documents that must be planned and managed in terms of time and resources to ensure this efficient clinical execution that best allows to proceed successfully to further phases.
Asphalion has a broad experience in this matter with regards to:
During the first steps of clinical development stage, preliminary data consolidation and aggregation become fundamental to ensure an appropriate safety and efficacy profiling that best validates a pharmaceutical to proceed. Particularly for early clinical phases (Phase I and II) transferring all generated pre-clinical information to the clinical setting represents a big challenge.
Additionally, development requires to escalate the conclusions to larger, representative populations. These late phases of development are especially subjected to a highly complex regulatory context as the development approaches potential product registration and commercialization.
In order to guarantee success, the exact scope, timing and depth of clinical development plan must be strategically analyzed involving local regulatory authorities and stakeholders to ensure enough evidence generation according to regulatory requirements.
All this activity generates a strategic workflow of contacts, specific meetings as well as data and documents that must be planned and managed in terms of time and resources to ensure this efficient clinical execution that best allows to proceed successfully to further phases.
Asphalion has a broad experience in this matter with regards to:
Clinical development stage Solutions
1) Regulatory roadmap oriented towards future product commercialization:
2) Strategic consultancy throughout the clinical development plan.
3) Regulatory Tools
4) Support in Scientific Advice meetings with regulatory authorities, including strategic and operative support in the meeting. Preparation of Briefing Package, attendance to meetings with authorities and adequation of the meeting content to comply with company plans.
5) Medical writing services for clinical and non-clinical evidence generation, including:
6) Support in clinical trial applications and submissions in EU/FDA:
7) Paediatric Investigational Plan (PIP)
8) Management of Orphan Drug Designation (ODD) procedure in EU and US:
9) Pre-approval development support in UK market application and entity requirements:
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Why Asphalion?
Asphalion knows and can handle with experience the different intermediaries, stakeholders, regulations, necessary documents and tools that are needed throughout the early phase of clinical development in order to maximize the transfer of pre-clinical research to a clinical setting in a strategic manner that best responds to their client’s commercialization objectives.
Asphalion has more than 20 years of experience both in administrative support and management in clinical trial applications and maintenance, as well as in medical writing activities and regulatory strategy focused on the generation of clinical evidence oriented to comply with requirements that are demanded by the variety of regulatory authorities within EU or the USA. This activity is highly fostered and facilitated by a wide experience [LM1] in the dialogue and management of communications with such authorities in parallel to trial performance, which is of utmost importance given the wide scope of the trials conducted and the information generated in this phase of development.
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