Clinical Trial Applications

PharmaLex provides support for all aspects of Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.

With our global understanding, we are with you every step of the way. The PharmaLex team can strategize and support multi-market and regional programs to meet your study needs, as well as helping you build a positive relationship with national competent authorities and ethics committees. 

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    High-quality time-adherent CTA and IND applications

    Our network of regulatory experts and trusted affiliates deliver high-quality time-adherent CTA and IND applications, as well as comprehensive management of post-submission activities.

    Alongside large pharmaceutical companies, we work with SMEs (including start-ups), virtual operations and academics, and have experience in a wide range of therapeutic areas and dosage forms.

    You can be confident of meeting your clinical trial regulatory requirements during your development journey with our specialist support and advice.

    We offer global solutions covering the entire product lifecycle

     Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.

    Clinical Trial Authorization and Investigational New Drug by

    • Coordinating multinational, global submissions
    • Providing strategic advice and guidance on Clinical Trial application preparation based on market-specific expertise, in order to address and minimize the risks of any validation queries or grounds for non-acceptance that may arise during assessment
    • Authoring market-specific and local documentation, including the adaption of core patient-facing documents, such as the Informed Consent Form (ICF)
    • Supporting translation of documents through our specialist translation partner
    • Compilation and/or publishing of final submission packages
    • Handling the submission process to National Competent Authorities and Ethics Committees according to local requirements
    • Effectively liaising with the authorities to obtain successful conclusions
    • Supporting post-submission activities including response to questions, trial amendments (substantial and non-substantial), and end of trial notifications

    Clinical Development by

    • Creating a Target Product Profile (TPP)
    • Designing and developing individual protocols/synopses
    • Authoring and/or performing the technical review of core documents such as the Protocol, Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD), and labeling
    • Conducting gap analyses of existing documentation to provide guidance on outstanding requirements and supporting the closure of identified gaps
    • Authoring of EU and US pediatric plans, waivers, and deferrals
    • Authoring clinical study reports
    • Managing the overall clinical development program and monitoring progress and budget
    • Identifying and managing the clinical program risks and issues and taking corrective actions
    • Coordinating the projects and vendors required for the clinical program and their interdependencies and managing resources across projects

    Available Resources

    Related Services

    PharmaLex provides global Clinical Development / Clinical Regulatory expertise to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs. This includes software for management of trial master files, resources for day-to-day processing of trial content and associated expert consultancy through one of the PharmaLex family of companies.

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    Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development strategies needed.

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    Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at PharmaLex have mastered the science of toxicological risk assessment and have helped products sail through rigorous regulatory scrutiny and reach the market.

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    Global Approach

    PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

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