Clinical development stage

Product-specific regulatory support for optimal transfer from pre-clinical data to a clinical development stage to meet with regulatory requirements

Clinical development stage

During the first stages of clinical development, 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:

  • Regulatory timelines regarding procedures within clinical trials.
  • Clinical aspects related to data retrieval and presentation oriented to achieve excellent evidence generation according to strategy.
  • Potential contacts and advisories with involved authorities, clinicians, sponsors, and study centers.

During the first stages of clinical development, 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:

  • Regulatory timelines regarding procedures within clinical trials.
  • Clinical aspects related to data retrieval and presentation oriented to achieve excellent evidence generation according to strategy.
  • Potential contacts and advisories with involved authorities, clinicians, sponsors, and study centers.

Our Solutions

1)    Regulatory roadmap oriented towards future product commercialization:

  • Strategic regulatory and scientific assessment by providing advice on preclinical requirements, CMC aspects and  clinical development plans to bring your product to the patient in the most efficient way.
  • Regulatory gap analysis at all stages of development.
  • Feasibility assessment, including overview of clinical development plans, timelines and costs

 

2)    Strategic consultancy throughout the clinical development plan.

  • Advise on data selection, evidence and endpoints to be presented to comply with proposed objectives, as well as support in target population definition.
  • Selection of study adequacy to ensure optimal regulatory strategy and data presentation.
  • Costs and timelines management.
  • Advise on study protocol definition from regulatory perspective.

 

3)    Regulatory Tools

  • Classification of your company as SME (Small Medium Enterprise), with the waivers and facilities this involves.
  • Strategy search for fast-track regulatory accelerated assessment tools: PRIority Medicines (PRIME) programme; accelerated assessment, future conditional approval, compassionate use, etc.
  • Potential waivers definition.

 

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.

  • Meetings with National Competent Authorities (NCAs) in Europe.
  • EMA: Scientific advice meetings (contextualized for each product), protocol Assistance, Innovation Task Force (ITF)
  • FDA meetings in multidisciplinary or CMC-based focus with Asphalion US expert partner: Type A (clinical holds and dispute intermediation), Type B (Pre-IND, EOP2 meetings) and Type C meetings.

 

5)    Medical writing services for clinical and non-clinical evidence generation, including:

  • IMPD (Investigational Medicinal Product Dossier) and IB (Investigator’s Brochure) generation and update.
  • Investigational New Drug applications (IND) in US.

 

6)  Support in clinical trial applications and submissions in EU/FDA:

  • Clinical Trial Application (CTA), also those based on the new Regulation by CTIS in EU.
  • Investigational New Drug applications (IND) preparation and submission in US.
  • Clinical Trial Application in UK.

 

7)    Paediatric Investigational Plan (PIP)

  • Regulatory strategy, preparation and submission management of Paediatric Investigational Plan (PIP) for EU and Pediatric Study Plan (PSP) for US
  • UK PIPs.

 

8)    Management of Orphan Drug Designation (ODD) procedure in EU and US:

  • Pre-submission of ODD.
  • Preparation of ODD applications including: significant benefit, prevalence calculation and medical plausibility.

 

9)    Pre-approval development support in UK market application and entity requirements:

  • National Scientific Advice with MHRA
  • UK Orphan Drug Designation Application
  • UK PIP
  • Clinical Trial Application

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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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