Clinical Operations

Clinical Operations

Clinical Operations

Our flexible approach and rapid scalability means we are equally strong managing small discrete projects to full-service multi-country Phase III trials.  We have the expertise and systems to manage all clinical operations activities on your behalf, from early protocol development through to regulatory and ethical submissions, site selection and initiation, trial site monitoring, data management & biostatistics, TMF management and CSR production and study closeout.  We are able to conduct activities on a truly global scale utilising our teams in Europe, North America and Australasia providing access to a huge number of trial sites across multiple therapeutic areas and disciplines.  We work with a variety of clients from Top 10 Pharma to small, virtual biotech organisations, but our commitment and dedication to all our clients is unchanged regardless of their size or the scope of work.

We use a number of systems to deliver your projects including an electronic Trial Master File, Electronic Data Capture system and bespoke tracking tools designed for your studies.  However, we do not impose these systems on our clients, and will work to implement the systems and processes which suit you and your studies to best effect.  Our commitment to patient safety and quality is paramount and we work closely with the Emas QA department to ensure regulatory and any local requirements are met at a minimum.  Throughout all these activities our senior managers provide oversight and leadership to ensure studies are delivered to time, quality and budget.

Summary of Services

  • Protocol Development
  • Global Clinical Trial Authorisation (CTA) submissions
  • ­FDA IND submissions
  • ­Global EC/IRB submissions
  • ­Management of regulatory and ethics approvals (including annual updates, end of trial notifications)
  • ­Legal Representative services (EU & ROW)
  • ­IP Management (formulation, import licence, depot management)
  • ­Global clinical project management
  • Study feasibility
  • ­Study site selection and qualification
  • ­Clinical monitoring using a global network of experienced CRAs
  • ­Phase I unit monitoring and management
  • ­Risk based & remote monitoring
  • ­Support and management of investigator led studies
  • ­Trial Master File management (including eTMF)
  • ­Data Management (including EDC provision)
  • Biostatistics

Regulatory and Ethics Submissions

Within the Clinical Operations department we manage the submission to regulatory authorities and ethics committees in all regions (including the USA).  Our Project Managers are experts in the different country and regional requirements and will work with you to collate the documentation packages which the authorities and ECs/IRBs require.  By managing these activities within Clinical Operations the Project Managers and CRAs are involved with the studies from the earliest possible point, and can carry this knowledge and experience through to the clinical conduct phase.  Our Project Managers will also manage all ongoing submission requirements including protocol amendments, end of trial notifications and submission of the CSR.


Clinical Trial Site Management

Clinical Research Associates at Emas have experience of managing sites across multiple phases and therapeutic areas including oncology, acute medicine and healthy volunteer trials managed in Phase I units.  The experience of our CRAs ensures that they are able to manage sites conducting complex protocols and are able to do this via a full on-site monitoring process or a more risk-based central approach depending on the requirements of the trial and the client. The CRAs are also used to supporting sites working with multiple Electronic Data Capture systems and are able to operate flexibly whilst ensuring the rights and wellbeing of the subjects and integrity of the study data are maintained.


emas clinical operations

Data Management

Data Management is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

Our data management department ensures that data is collected, complete and consistent and we support the conduct, management and analysis of studies across all therapeutic areas. Using recognized EDC systems  & new novel cloud based system to match study requirements or customer preference. Our data management team is involved in early discussions about data collection, options and then oversees development of data collection tools based on the clinical trial protocol.

 


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