Clinical Development

We assemble bespoke, flexible, expert teams to guide and support our clients to select the most effective route to market, ensuring maximum return on investment. By offering strategic leadership and deep operational expertise we navigate the complexities of the clinical development landscape. Starting with the desired outcome, we support development and delivery of clinical development plans that address the critical questions, enabling earlier, more confident decision-making.

Strategic Expertise

Strategic Expertise

Operational Excellence

We partner with development companies to accelerate the market launch of new therapies while upholding the highest standards of safety and quality. Our commitment is to advance therapeutic innovations through careful planning, rigorous management, and comprehensive oversight of regulatory processes and clinical trials.

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Maximise the value of your products with our bespoke solutions.

Extensive Therapeutic Area Knowledge

Drawing on our vast experience across diverse therapeutic areas, we offer insightful guidance and support. Our team is highly knowledgeable in disciplines including oncology, infectious diseases, immunology, neurology, respiratory, and rare diseases. This deep expertise allows us to tackle complex challenges and deliver tailored strategies that address specific therapeutic needs.

Clinical Development Strategy and Planning

Success in clinical development hinges on strategic foresight. We provide expert consultation from initial concept through regulatory licensure, combining industry best practices with innovative methodologies. Our approach ensures optimal target product profiles and robust development plans that align with our clients’ objectives.

Provision of C-Level Individuals to Entire Clinical Development Teams

Our extensive network of expert physicians, scientists, and functional leaders, coupled with our flexible solutions, makes us a compelling partner. We offer:

  • Interim placements up to C-level and functional service teams
  • Design and delivery of large, complex, cross-functional development programs
  • Serving as the drug development organisation for companies
  • Interpretation of complex clinical trial outcomes and steering of regulatory authority discussions
  • Multifunctional submission teams for authoring and delivering MAAs and NDAs
  • Full oversight and management of all drug safety needs

Our Clinical Development Teams focus to deliver a pragmatic strategy, ensuring high-quality data collection and documentation to support an efficient path to market authorisations globally.

Comprehensive Clinical Trial Design

Our expertise encompasses the design of intricate clinical trials tailored to your research objectives. We balance scientific rigor with practical considerations, ensuring optimal trial designs for efficacy and safety evaluation. From protocol development to trial recruitment strategies, and reporting, we meticulously plan every aspect of your trial.

Complex Data Review, Interpretation, and Recommendations

Navigating complex data is essential for meaningful insights. Our team excels in comprehensive data review and interpretation, employing advanced analytics to deliver actionable insights. We provide clear, data-driven recommendations that guide decision-making and optimise trial outcomes.

Selection and Oversight of Contract Research Organisations (CROs) and Vendors

Choosing the right partners is critical for successful trial delivery. We offer expert support in selecting and overseeing CROs and vendors. Our rigorous evaluation process ensures collaboration with top-tier professionals, while our robust, risk-based oversight guarantees high standards of data quality, validity, and compliance.

Clinical Trial Oversight & Delivery

Effective oversight is fundamental to maintaining trial integrity. We provide comprehensive oversight throughout the clinical trial lifecycle, including medical and safety oversight and adherence to regulatory and ethical requirements. Our proactive approach identifies and addresses potential issues to keep your trial on track and within scope.

Timely and budget-conscious clinical trial delivery is vital for advancing medical research. Our Clinical Trial Delivery team ensures seamless execution from initiation through completion, offering:

  • Project Management: Leading and coordinating all trial aspects, including timelines, budgets, and resources.
  • Site Management: Engaging and managing trial sites, ensuring compliance and strong relationships with site staff.
  • Patient Recruitment and Retention: Developing strategies to enhance recruitment and retention.
  • Risk Management: Identifying and mitigating risks early to maintain study timelines and outcomes.
  • Quality Assurance: Monitoring trial processes and data quality for compliance with GCP and regulatory standards.
  • Qualification and Oversight of Specialist Vendors: Managing the selection and oversight of vendors such as central laboratories, data management services, pharmacovigilance, and eTrial Master Files.

Medical Monitoring

Patient safety and trial success hinge on vigilant medical monitoring. Our experienced medical monitors provide vigilant oversight to ensure the highest level of safety and compliance. We oversee adverse event reporting, conduct safety reviews, and offer expert medical input to address any concerns that arise during the trial.

Safety Management

tranScrip can provide comprehensive pharmacovigilance (PV) services to support clinical programmes including PV inspection readiness and training, trial planning, and end-to-end safety signal management. We have access to a regulatory compliant in-house safety database and support Data and Safety Monitoring Board (DSMB) activities. We support all trial requirements including review of CIOMS, SAE narratives, coding and oversight of PV vendors.

Medical Writing

Clear and accurate documentation is vital for regulatory compliance and effective communication. Our skilled medical writers specialise in creating high-quality documents that meet regulatory standards and facilitate clear communication with stakeholders. From clinical trial reports and regulatory dossiers to protocols, paediatric plans and manuscripts, our writing team ensures that all documentation is precise, comprehensive, and tailored to your needs.

Regulatory Affairs

Navigating the global regulatory landscape is crucial for successful therapy development and commercialisation. Our Regulatory Affairs team provides:

  • Regulatory Strategy: Crafting strategies aligned with clinical development plans for optimal licensure including expedited pathways combining CMC, pre-clinical, clinical and labelling expertise.
  • Submissions and Interactions: Preparing and submitting documents to regulatory bodies like the FDA and EMA, managing communications to resolve issues smoothly.
  • Compliance: Ensuring trials and submissions comply with evolving regulations.
  • Regulatory Intelligence: Monitoring trends to anticipate changes and adapt strategies.

Quality Assurance

Our QA team ensures that all aspects of the clinical trial process adhere to regulatory requirements and industry standards. This includes:

  • Audits: Conducting audits and assessments to qualify or to assess compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
  • Quality Management System (QMS): Developing and maintaining a comprehensive QMS to standardise processes and ensure consistent quality across all trial activities.
  • Continuous Improvement: Implementing a culture of continuous improvement through feedback loops, training, and process optimisation.
Perfectly positioned

Perfectly positioned

for a unique partnership

With extensive and diverse expertise, tranScrip’s professionals support activities typically managed in-house by pharma companies. Our teams of clinical development and operations experts, clinicians, statisticians, and research scientists deliver exceptional results. Seamlessly integrating as an extension of our clients’ teams, we offer flexible resources that adapt swiftly to evolving needs.

Case Study

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Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.