Elliot Brown Consulting Ltd

Services

Elliot Brown Consulting - Pharmacovigilance Services

The monitoring of clinical trial safety and the continuing surveillance of marketed medicines are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and specialist knowledge is needed to fulfil the stringent obligations. In addition, the occurrence of a new safety concern with a medicine can have the most serious consequences and needs effective and timely management.

Services on offer from Elliot Brown Consulting include:

Routine safety surveillance and signal review
Safety strategy, procedures and systems
Review of new safety issues
Preparation or review of periodic safety update reports
Advice on investigation of safety signals
Representation to regulatory authorities
Review of benefit-risk
Crisis management
Review of safety studies / post-authorisation surveillance studies (SAMM / PASS)
Audit of company, department or site practices and procedures
Training on pharmacovigilance
Assistance with Third party agreements / contracts
Assistance with database implementation
Advice on safety surveillance for devices
Organisational review and change management
Data Safety Monitoring Boards
Medicolegal Consultancy

Elliot Brown has collaborative relationships with consultants in the United States, to provide a global perspective and to facilitate cost-effective work on both sides of the Atlantic.

MedDRA® Services

The recent arrival of MedDRA® (Medical Dictionary for Regulatory Activities) as an international standard will provide pharmaceutical companies and regulatory authorities with many benefits, but undoubtedly requires much work in implementation and especially in changing working practices regarding data retrieval and analysis. Getting it wrong may prove catastrophic!

Elliot Brown has been personally involved in the international development of MedDRA from its inception and has written most of the published scientific literature on the topic. MedDRA services available include:

Basic MedDRA training
Training the trainers
Company needs assessment
Assistance with MedDRA implementation
Assistance with initial MedDRA use
Advice on data retrieval and analysis strategies with MedDRA
Ad hoc advice and information
Legacy database migration
Coding services, in conjunction with BMS Consulting
Preparation of standardised database queries
Authoring coding manuals and SOPs

Medical and Regulatory Services

As the regulatory and clinical research environments become increasingly complex, time and resource are at a premium within medical departments. Elliot Brown has resource and extensive experience in all aspects of medical services and can provide a cost-effective and flexible service tailored to customer needs.

Services from Elliot Brown Consulting include:

Preparation or review of Clinical Expert Reports
Advice on regulatory strategy
Literature review
In-licensing review
Representative and medical department training
Medical input to marketing strategy
Preparation or review of SOPs
Preparation of SPCs, Core Data Sheets, Patient Information Leaflets
Representation to regulatory authorities

Elliot Brown Consulting Ltd
Registered Office:
Russell House,
140 High Street,
Edgware,
Middlesex HA8 7LW
Registered in
England and Wales.
Reg No. 3691390