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Cockburn Consultancy Services Ltd

Cockburn Consultancy Services Ltd (CCSL) offer a range of pharmaceutical consultancy services, including interim management, education and crisis management.

CCSL take pride in offering a bespoke on-demand service to its clients. Whether advice is required on-site or remotely, CCSL are always available to respond to casual or formal, regular or irregular enquiries or requests for advice and assistance. Drawing on the considerable experience of their consultants, they can ensure a professional and ethical position which will benefit both sides of the partnership.

Interim management solutions


CCSL have considerable experience in providing interim management solutions to small, medium and large pharmaceutical businesses. They specialise in the configuration and facilitation of small to medium pharmacovigilance departments, global integration of disparate regional units, business process re-engineering and the development and consolidation of effective international adverse event systems. Case examples include:

- Building a European regional office from scratch, creating and maintaining European standards, and enabling a strong network across 15 European member states.

- Developing an international adverse event system, from needs analysis, through client selection to installation, configuration and system validation. Experience also included the development of a "Japanised" version.

- The creation of two corporate safety committees for a top ten pharmaceutical company; one for overseeing worldwide safety standards, and the second setting and maintaining global safety label statements. In parallel, the corporate central safety office was modernised, through a process of integrated business process re-engineering, thereby reducing process steps by over 50% and enhancing efficiency by sustaining headcount despite an environment of increasing adverse event volumes.

With over twenty years of pharmacovigilance experience to draw from the staff at CCSL have acquired much knowledge from their management of major safety issues and product crises. In each case these were satisfactorily resolved.

Case histories


An antidiarrhoeal was shown to be inappropriately promoted in a third world environment in a major TV documentary. While the sister company's product was being pilloried by the media, under CCSL’s guidance the sponsor company quietly performed a risk assessment, corrected and realigned its promotional campaign in an ethical manner and was able to continue to market its product range with no adverse publicity.

A major Western authority requested a Benefit Risk Assessment for a product. Challenging enough, but in this instance the product was a device with an unusual use, and limited clinical data to support it. During an intense two month period, CCSL drew on epidemiologcal data and clinical models, and assisted the manufacturer to prepare what is believed to be the first such benefit risk assessment in Europe. This was accepted by the regulator and the issue was resolved.

A severe implementation fault in a clinical trial resulted in a significant avoidable injury to a patient and threatened the integrity and corporate standing of the company. An effective crisis management team took control under the leadership of a member of CCSL and managed the evaluation of the issue including establishing cause and effect, preparing internal and external press communications, rectification of the process defects, whilst maintaining the ethical integrity of the involved company.

A major Western authority withdrew a company's leading product on safety concerns. CCSL adopted a two pronged approach; maintaining confidence in the product in other significant markets, and performing a full evaluation of the issues involved including significant pharmacoepidemiological, scientific, and medical analyses. The recommendations of CCSL led to a successful defence of the product and a withdrawal of the regulator's actions. Sales were minimally affected during the crisis and rapidly recovered thereafter.

CCSL have been actively in advanced education in pharmacovigilance for over 20 years. One of their staff is a member of a small syndicate who recognised the need, 10 years ago, for formal pharmacovigilance training for Qualified Persons for Pharmacovigilance. They devised a suitable programme, interviewed and selected a suitable university and steered the inauguration of the programme, the selection of suitable lecturers, and the format and content of examinations.

Pharmacovigilance lectures and presentations


CCSL are well known for their lectures in pharmacovigilance, and have a long record of presentations in a wide range of topics for various organisations including IIR, Management Forum, AIOPI, and ISOP. They also maintain a keen interest in communicating on pharmacovigilance to a broader audience. They have expanded their educational facilties with three new sites:

- www.drugsafety.info provides interest information for amateurs and professionals alike in pharmacovigilance.

- www.pharmainteractive.com provides e-learning capabilities with both fixed and bespoke educational materials for the early and intermediate professional

- www.compliancebenchmark.com provides benchmark data that compares the expedited reporting compliance of a sponsor company with those of other competitors.

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