Fully managed clinical trials, carefully planned, executed and assessed from start to finish.

Acceler8 Clinical Research conducts clinical studies for pharmaceutical, biotechnology and medical device companies. Our clinical trial development processes facilitate commercial efficiency and cost effectiveness in helping bring clients’ products to market. We are used to working with clients who have to be efficient with their resources. Our team are flexible in working in changing environments and are able to manage your clinical programme from concept, through to marketing application if required. 

Our success is achieved through recruitment and development of high calibre staff. Customer loyalty is also an important factor in our success. All of our sponsors have awarded us repeat business and/or recommended us to other organisations.

Acceler8 Clinical Research has a wide range of therapeutic area expertise and all of our personnel have direct, hands on experience of Clinical Trials and ICH GCP with the ability to provide a real world insight into the role. 

Project Management

  • Project needs assessment and contingency planning
  • Overall project planning and communication planning
  • Resource allocation and team management
  • Risk assessment, tracking and management
  • Budget development and tracking
  • Management of project timelines, teams and deliverables

Clinical Trial documentation preparation

Design/review/translation of:

  • Protocol
  • Investigator Brochure
  • Master Informed Consent Form
  • CRF
  • Pharmacy Manual
  • Operations Manual
  • Clinical Monitoring Plan
  • TMF set up and management

Quality Management System and auditing Services

  • Internal and external audits (GCP, GLP, GPvP and GMP)
  • Statutory GCP and GMP preparation and inspection (FDA, EMEA, MHRA)
  • Quality Management System development
  • Review of quality systems and legacy operations
  • Standard Operating Procedure evaluation and generation
  • Process Mapping
  • Documentation management
  • Staff training
  • QP services

Clinical Monitoring and Site Management

  • Feasibility
  • Site identification and qualification
  • Investigator Site set up and initiation
  • Recruitment planning and tracking
  • IMP Management
  • Routine Monitoring visits
  • Site Management
  • Motivational visits
  • Site audits
  • Resolutions ad responses to queries
  • Site close out visits

Data Management

  • CRF Completion guidelines
  • CRF Tracking
  • Database design
  • Data entry/editing/verification
  • Data coding
  • Reconciliation of SAEs
  • Medical Review of CRFs
  • Management of external imports
  • Database lock

Statistical Analysis

  • SAP development
  • Programme listings, figures, tables
  • Final analysis & Statistical report

Pharmacovigilance

  • Development and maintenance of database
  • Preparation of case narratives
  • Expedited SUSAR reporting
  • Query resolution to case closure
  • Medical Coding
  • Development of DSUR

Regulatory Consultancy

  • Regulatory Submissions
  • Ethics Submissions
  • CSR preparation
  • Protocol & CSR Synopsis preparation
  • Manuscripts preparation for publication

Medical Monitoring

  • Medical Monitoring 24/7 cover
  • Medical assessment of subject eligibility
  • Medical review of data listings
  • Therapeutic area of training
  • Protocol and project-specific safety training at investigators meetings

Other

  • Pre-Clinical Development
  • Clinical Trial Packaging
  • Central Lab Managment
  • Contract Preparation and negotiation