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uno clinical operations

due v

quattro clinical operations

Clinical Operations

Always providing fully-customisable services to fit the objectives of your clinical development

Our portfolio of Resourcing solutions offers customers a flexible, cost-effective alternative to full-service outsourcing.

We support the specific goals and objectives of our customers, providing resourcing solutions across one or more of these clinical development service areas, gaining exceptional operational management and technical expertise.

  • Clinical Research Associate
  • Statistics and Programming
  • Regulatory Affairs (Study submission to CAs and CEs)
  • Data Management
  • Pharmacovigilance and Drug Safety
  • Quality Assurance and Quality Control (GCP Auditing)
  • Clinical Operation (Project Management, Site Management, Monitoring)
  • Medical Writing
  • Medical Science Liason

Key benefits include:

  • Ability to leverage full service
  • Ability to dynamically allocate resources when needed
  • Gain expertise of dedicated Operations Manager
  • Flexibility to manage study size, trial speed
  • Established and reliable site relationships, critical for on-time delivery and rapid patient recruitment

Pharma D&S has a long-standing experience with local authorities and ethics committees, making it possible to find the fastest solution for every study, delivering outstanding quality, performance services.

Pharma D&S has extensive experience with most of the drug and treatment types like dermal, endocrine, oncology.
An experienced Project Manager has the overall responsibility for the conduct of your clinical study and will be your single point of contact, for maximum flexibility and efficiency.

Our CRA are located to provide local monitoring and the confidence that studies are being conducted to the highest standard, in compliance with ICH GCP, to ensure the quality and success of the study.

Quality in Clinical Research

Our Quality Assurance team provides independent oversight and auditing to ensure the data integrity of every clinical study.

Our Quality team is involved in every project and has a solid relationship with our clients, sites and vendors.

We offer different execution models which focus on provision of resourcing capacity and functional expertise to complement our global customers’ internal teams.
These resourcing models are fully-customisable to fit your clinical development objectives, whether you need support in a single function, multiple functions, a specific therapeutic area or phase, or across your entire portfolio.

Long term resourcing solutions

Identification and long term resourcing of talent for your team.

  • Contingent Resourcing
    Deployment of temporary or contingent resources to meet unforeseen or short -term needs
  • Program In-sourcing
    Deployment of project or programme specific teams for a defined period and scope of work
  • Strategic Capacity Management
    Provision of a strategic large scale resourcing solution to support fluctuating
  • Functional Service Provision
    Management and execution of an entire function on behalf of the sponsor
  • Hybrid Service Delivery
    Combination of FSP and traditional outsourced models to create integrated solution
  • Clinical Program Development
  • Clinical Trial Application
  • Health Authority/ agency Interaction
  • Clinical Operations
  • Pediatric Investigation Plan (PIP)
  • Scientific Writing
  • Statistical Services
  • Global Procedure Management