Clinical Activities
Scendea’s expert team delivers strategic and operational support in the fields of Non-Clinical, CMC, Clinical and Regulatory Affairs.
clinicalClinical Development Plan
A Clinical Development Plan (CDP) is a fundamental element of successful clinical development, requiring meticulous consideration, clear documentation, and structured organisation. We excel in crafting comprehensive CDPs, serving as internal corporate management tools, providing tactical oversight at various stages, and positioning your clinical development endeavours for optimal outcomes.
Clinical Gap Analysis
A Clinical Gap Analysis delves into the critical aspects of your clinical development, identifying potential obstacles that could impede your progress to the next developmental stage. Our experts conduct a comprehensive gap analysis, with a specific focus on the geographical coverage pertaining to a client's Product and Indication. This analysis will entail a meticulous review of the data package provided by the client to ascertain the additional information necessary for achieving the next stage of development or fulfilling the regulatory objectives.
Clinical Strategy Development
At Scendea, we offer an extensive range of services related to Clinical Strategy Development, including Strategy Workshop and analysis/interpretation of clinical data...
Strategy Workshop
A Clinical Development Strategy Review and Workshop is an exercise that offers the opportunity for our team of experts to review your Clinical Development Strategy and present any gaps &/or suggestions in the form of a report and workshop to discuss the findings and offer suggestions within the review. A Clinical Development Strategy Review can occur at any stage of development, however Scendea would typically recommend this activity occurs early in the relationship with the sponsor, ahead of any Clinical Trial. This activity will provide you with the information pertaining the suitability of the CTP's readiness for submission to the appropriate Authority.
Clinical Study Reports (CSRs)
A Clinical Study Report (CSR) is a comprehensive document that encapsulates the methods and findings of a clinical trial. At Scendea, we excel in the authoring of CSRs, strictly adhering to the guidelines outlined in ICH Guideline 3, "Structure and Contents of Clinical Study Reports".
Clinical Risk-Benefit Assessment
A Clinical Risk-Benefit Assessment is a pivotal component in ensuring the success of medical interventions, demanding careful evaluation, precise documentation, and strategic organisation. Our expertise lies in the meticulous crafting of comprehensive Risk-Benefit Assessments, serving as invaluable tools for regulatory submissions and internal corporate management. Whether authoring or reviewing the Risk-Benefit section of the Investigational Medicinal Product Dossier (IMPD), our services also extend to the corresponding sections of the Investigator's Brochure (IB) and protocol.
DSURs & PSURs/PBRERs
At Scendea, we can author, update and/or provide a complete review of your DSUR, PSUR and/or PBRER.
DSURs, PSURs and PBRERs are documents that provide an ongoing assessment of the safety profile of a medicinal product. They are submitted to regulatory authorities, such as the EMA and FDA, to ensure that the safety of a drug is continuously monitored and evaluated.
Due Diligence Activities
Whether your objectives involve strategic acquisitions, investments, or out-licensing opportunities, making well-informed decisions requires a meticulous and precise analysis of existing scientific data.
At Scendea, our expert team specialises in both high-level assessments and comprehensive deep dives. Our Due Diligence activities identify crucial gaps in Non-Clinical, CMC, and Clinical data, pinpointing potential risks that could hinder the progression of your projects in US, EU and UK markets.
Orphan Drug Designation
Scendea specialises in providing comprehensive support for Orphan Drug Designation (ODD) applications. With our dedicated team, you can navigate the intricacies of ODD applications with confidence, increasing the likelihood of obtaining ODD.
Our ODD services include:
Development of an optimal strategy to ensure a successful ODD application.
Expert authoring or thorough review of ODD applications, including prevalence/incidence calculation.
Procedural guidance and submission support, ensuring that every aspect of the ODD process is meticulously managed.
Paediatric Development
Scendea provides comprehensive support with paediatric development, including but not limited to:
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Paediatric Development Strategy Workshops
Our workshops are designed to provide an in-depth assessment of your current paediatric development strategy. We conduct a meticulous analysis of the literature relevant to your indication, ensuring alignment with the requirements of a Paediatric Investigation Plan (PIP) in Europe and the UK. Our experts guide you in refining your strategy, equipping you with the knowledge and insights necessary for successful paediatric development.
Paediatric Development Strategy Document
Our strategy document outlines the paediatric subsets where a waiver will be proposed, and include a high-level outline of proposed studies to be included in the Paediatric Investigation Plan (CMC, non-clinical and clinical, as applicable), as well as the proposed duration of deferral, as applicable. The strategy plan, once agreed, will serve as the basis for preparation of the PIP.
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Scendea can support with authoring and/or review of your PIP/PSP (including waiver and deferral applications). We also offer PIP/PSP procedural and submission support and can manage all interactions with the EMA, MHRA and/or FDA.
Programme/Project Management
Scendea provides specialised programme/project management services tailored towards preparing a client's product for clinical trials or attaining regulatory approval in a streamlined and cost-effective manner.
Our comprehensive programme/project management encompasses all aspects, including manufacturing/quality, non-clinical development, and clinical development. Alternatively, we offer focused management services for specific aspects of a development plan. We excel in generating detailed project plans, creating timeline charts, and implementing robust document/version tracking systems to ensure seamless progress in your projects.
Protocol Development
Scendea specialises in authoring and reviewing comprehensive clinical protocols, providing expert guidance from Protocol Synopsis creation to detailed Protocol Development, including meticulous study design, clinical endpoints, inclusion/exclusion criteria, and sample size calculations.
Regulatory Approval to Undertake Clinical Studies
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The creation of an Investigational New Drug (IND) dossier is a critical step in seeking FDA authorisation for human clinical trials and interstate shipment of an experimental drug. This dossier serves as the foundation for these activities before marketing application approval is granted. With expertise spanning Non-clinical, CMC, and Clinical aspects, our experts intricately integrate these vital elements into your IND dossier, ensuring seamless alignment with the FDA's rigorous standards, positioning your submission for success by being comprehensive and precise.
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A CTA is a regulatory application submitted to the UK MHRA and/or EU authorities, outlining comprehensive details of a proposed clinical trial, including study objectives, design, participant criteria, and safety measures, seeking approval to conduct the research in compliance with established regulatory standards. Scendea excels in the meticulous compilation and submission of CTA Applications, encompassing both UK MHRA and EU regulatory requirements, ensuring seamless and compliant processes for initiating clinical trials.
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A New Drug Application (NDA) or Biologics License Application (BLA) is a regulatory submission for the approval of a new medicinal product. This comprehensive application encompasses exhaustive details on the product's safety, efficacy, and quality, including data from clinical trials, manufacturing processes, and risk-benefit assessments. Scendea specialises in the compilation and submission of NDA/BLA documents, ensuring alignment with FDA regulatory standards.
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A Marketing Authorisation Application (MAA) is a detailed regulatory submission, provided to both EMA and the MHRA, thoroughly outlining a medicinal product's safety, efficacy, and quality. Scendea specialises in efficiently compiling and submitting MAAs, helping secure approval for commercialisation.
Agency Interactions
Frequent engagement with global regulators is vital for successful pharmaceutical development. Scendea excels in representing you during critical meetings with the US-FDA, EU-EMA, UK-MHRA and other national authorities. Our team collaborates closely with you to optimise interactions, aligning your strategies with regulatory expectations for a more successful development journey. We also craft comprehensive briefing documents to support regulatory agency/authority interactions, act as the regulatory primary point of contact (including providing US agent services) and promptly respond to agency inquiries. This meticulous approach ensures that every engagement with authorities adds substantial value to your product development.
In addition to the above, we craft well-structured responses to agency inquiries and information requests, maintaining the momentum of your application during evaluations.
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Type A/B (Pre-IND)/C/D
INTERACT Meetings
Pre-BLA/NDA
US Agent Services
Scendea also offers US Agent Services. In this capacity, we assume the role of your US agent throughout the process of IND and Orphan Drug Designation (ODD) applications.
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ITF Meetings
EMA Scientific Advice
National Scientific Advice
Pre-MAA Meetings
Paediatric Scientific Advice
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MHRA Scientific Advice
Pre-Submission Meetings
Authoring & Review of Licensing Applications
We specialise in authoring comprehensive licensing applications in the US and EU, covering every critical aspect for regulatory approval. Our service encompasses the creation of Modules 1 to 5. These modules ensure a structured presentation of administrative information, overall summaries, quality details, non-clinical and clinical study reports, essential for effective regulatory evaluation. Our expertise also extends to providing expert assessment and sign-off for Module 2, offering a crucial layer of assurance for the application's overall summaries. We also offer extensive review and revision of existing licensing applications, ensuring your application adheres rigorously to safety, efficacy, and quality benchmarks.
Discover the list of applications we support…
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NDA
BLA
ANDA
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MAA (Centralised and National Authorisation Procedures)
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MAA
Technical / Medical Writing
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Scendea provides technical/medical writing services for Protocol development, including clinical or non-clinical/toxicology studies and Protocol Synopsis.
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Scendea specialises in the authoring of Clinical Study Reports (CSRs), meticulously adhering to the guidelines outlined in ICH Guideline 3, "Structure and Contents of Clinical Study Reports" and Drug Safety Update Reports (DSURs).
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Scendea excels in preparing core documents, including Investigator's Brochures (IBs). These meticulously prepared documents are crucial for enlightening investigators and trial stakeholders on essential protocol details, such as dosage, administration methods, dose frequency/interval, and safety monitoring procedures. Our proficiency in Regulatory Guidelines guarantees that your IB aligns seamlessly with standards, encompassing critical non-clinical aspects.
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Scendea provides specialised support for IND/NDA/BLA and MAA licensing applications, offering expert review, revision, and authoring of Modules 2.5, 2.7 and 5, including sign off/expert assessments.
