What we do

Developing and delivering complex projects with many different stakeholders requires a broad understanding of both the clinical and commercial environment. Prism services are focused on supporting the appropriate delivery of healthcare.

In practice, this represents a spectrum of activities that can be placed into the following categories:

Clinical programme consultancy

Clinical Programme Planning

Market evaluation
  • Clinical expectations
  • Medical need
  • Future trends
Goal Setting
  • Development path
  • Research objectives
Product attributes
  • Existing profile
  • Product review document

Clinical Trial Design and Implementation

Target Statements
  • Study design options
  • Endpoint choices
  • Statistical integrity
  • Supplementary data
Study support
  • SC and IDMC meetings
  • Ongoing review of safety data
  • Patient narratives
  • Study physicians
  • Medical monitoring
Study protocol
  • Defined by target statements
  • Medical content
  • ICH compliance
  • Internal consistency
  • Consent and IRB support

Internal and external scientific communications

Scientific communication

Safety reports
Case evalutation
DSMB reports
Communication strategy
Target product profiles
Meeting reports
Advisory boards and working parties
Competitor analysis
Literature analysis and review
Training materials
Key claims documents
Product attribute dossier
Objection handlers
Physician-led meeting facilitation

Other document and information summaries

IMPD and updates
Clinical study reports
Investigator brochures
Risk management plans
Core data sheets
Company core safety information
Developmental core safety information
CTD / IND support

External communications

Abstracts
Posters
Slide presentations
Primary manuscripts
Review articles
Symposia
Health Technology Assessment

Promotional copy review

Review of promotional copy provided by a client or an agency working on behalf of a client such that copy is wholly in line with territory-specific guidelines, codes and regulations

Editorial review
Technical and scientific review
Medical review
Medical sign off