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Clinical Development

Acting as an extension of your in-house team we support clinical study management and oversee the planning, design, submission and execution of all phases of clinical studies (Phase I – Phase IV). Our aim is to minimize the delay and administrative burden of the study start-up process and look for ways to move seamlessly from one development question to the next, without closing and opening sites, and/or stopping and starting recruitment where possible.
 
Our clinical consulting offering is designed to provide strategic advice on clinical development plans. Working in synchronization with our regulatory consulting services, we begin every consultation “with the end in mind,” meaning that we take into consideration what patients, regulators and clinicians will need in order to get maximum benefit from study design and readouts. This integrated approach allows us to help you stay ahead of the competition, prevent compliance or commercial risk by “de-risking” your development pathway as much as possible before MAA/BLA submission.

We realize project management and thought leadership are at the heart of the drug development process, and Trident provides clinical operations services that cover all phases of clinical trials, across multiple therapeutic areas. If you are seeking trial support in other markets, we have an extensive network of partners that allows us to deliver support globally.

Governance is a key part of our service offering at TBS and we pride ourselves not just in our technical ability to “give advice” but in our operational ability to “execute” workstreams using a robust project management methodology that ensures deadlines are met and KPIs are monitored/adjusted effectively.

Designing innovative trials is at the heart of what we do, and recent areas of key focus are providing input on “virtual” trial designs and components intended to reduce the barriers to study participation for patients, while simultaneously increasing the opportunity to get access to a diverse study population for our clients.

Lastly, we provide, on request, pharmacovigilance services as needed, to support pre and post approval e.g., RMP, PSUR, DSUR

Biostatistics and Data Analysis

  • Adult and Paediatric modelling (PK/PD) services and advice on endpoint selection

  • Study design evaluation and input

  • Sample size calculations and statistical analysis plans

  • Supporting sponsors with SA advice and responses to statistical queries from health authorities

  • Protocol design and writing

2

Clinical Operations and Management

  • Patient recruitment, monitoring and site engagement

  • Site selection and review

  • Project management and clinical vendor selection and management

  • Management of EC/IRB interactions and budget management

  • Database build, cleaning and support

  • Medical monitoring services

3

Medical Writing

  • Abstracts and literature searches to support internal and external meetings

  • Drafting of whitepapers or editorial content including press releases or media content for life science marketing teams

  • Protocols, Synopsis and Amendments

  • Informed Consent Forms (ICF) and Clinical Study Reports (CSRs)

  • Clinical Development Plans (CDP) and Risk Management Plans (RMP)

  • Labelling: Patient Information Leaflet (PILS) and Summary of Product Characteristics (SPC)

  • Regulatory submission documents: Investigators Brochure (IB), Module 2 and 5

  • Regulatory affairs strategy: Orphan Drug Designations, Paediatric Investigational Plans (PIPs)

  • Preparation and submission of CTA/ITA, IND, PMA/510(k)

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