Examples of projects listed by our key areas of specialist pharmaceutical technical expertise:

Research and early development
Product licensing
Regulatory affairs
Clinical development
Pharmacovigilance
Investigator brochure
Resource management and outsourcing
Training and staff development

Research and early development

Issues:
•	Poorly defined work processes and decision-making regarding evaluation of in-house generated candidate drugs meant that transition into clinical development was slow and inefficient.
Objectives:
•	Improve the quality and consistency of the in-house generation and evaluation of candidate drugs and support their transition into early clinical development.
Services:
•	Analyse current process and define new, improved process.
•	Produce supporting documentation to aid staff and decision-makers.
•	Centralise information in a user-friendly intranet site to support implementation of the improved process.
Benefit:
•	Clearly defined interface between Research and Development, including defined roles and responsibilities, and standardised documentation.
•	Globally communicated and understood process receiving appropriate input and resources from other relevant departments including Marketing and Production
•	Concise decision-making information, ‘go/no-go’ criteria and formally recorded decisions.

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Product licensing

Issues:
•	Product in-licensing was key to the company strategy but evaluations took too long and were very resource intensive.
•	Decision-making lacked transparency, objectivity and was inadequately recorded thus making company learning difficult.
•	A lack of consistency in the evaluation process, The evaluation process lacked consistency and there was inadequate supporting documentation.
Objectives:
•	Improve the quality and the consistency of the in-licensing evaluation process.
Services:
•	Review the current process and design improvement opportunities.
•	Produce checklists and templates to support both evaluators and decision-makers.
•	Centralise information in a user-friendly intranet site to support implementation.
Benefit:
•	In-licensing evaluation 30% quicker with decreased resource burden.
•	Concise decision-making information available with defined ‘go/no-go’ criteria and formally recorded decisions.

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Regulatory affairs

Issues:
•	The Regulatory Affairs (RA) function was decentralised and geographically dispersed.
•	It was considered beneficial to centralise the function but without loosing the regional expertise required to maintain the large and diverse product portfolio.
Objectives:
•	Recommend the most effective and efficient processes and organisation for global and national RA to optimally support the company’s business objectives.
Services:
•	Analyse current RA practice, develop processes that best meet customers needs then design the organisation which best supports these processes.
•	Support the implementation of the new global RA process and organisation.
Benefit:
•	A re-engineered global RA process and organisation.
•	RA process and geographical specialisation introduced into the organisational structure to optimally support the business.
•	Harmonised working practices and a more stable critical mass of expertise.

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Clinical development

Issues:
•	Recent centralisation of the Clinical function meant that there was little continuity or consistency of clinical processes. The department was overworked and underskilled, with poor quality of outsourced trials.
Scope:
•	Develop a two-year clinical operations strategic plan to build an efficient, effective and quality-focused department.
Services:
•	Collect relevant data, information and map the department’s processes.
•	Analyse data including GAP analysis using industry best practice and metrics for equivalent environment.
•	Prepare 2-year strategic plan and department vision and mission
Benefit:
•	Excellent buy-in for the plan from management and staff.
•	Rapid implementation of the plan resulting in increased level of quality and efficiency.

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Pharmacovigilance

Issues:
•	Fragmented and inefficient Pharmacovigilance (PV) function.
•	Potential risks resulting from sub-optimal handling of safety information
Scope:
•	Assessment and analysis of risks of international PV function.
Services:
•	Data collection, collation and analysis; functional risk assessment.
•	Recommendations for process and organisational improvements to minimise risks
Benefit:
•	Recommendations accepted by senior management and implemented with assistance of Calcis Consulting.
•	Risks identified and a risk management plan put in place leading to improved quality and efficiency of the process.

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Investigator brochure

Issues:
•	There were issues with Investigator Brochure (IB) quality and coordination problems between Medical Writers and Project Teams across sites in the US and Europe.
•	Input of numerous functions required for IB development and maintenance, however the process was inefficient and poorly understood by stakeholders.
Objectives:
•	Improve the IB process across the company in terms of stakeholder understanding and buy-in, process efficiency and IB quality.
Services:
•	Review and clarify the international IB process and suggest improvement opportunities.
•	Produce a user-friendly IB process intranet site to centralise process information, documentation and templates, learning and best-practice and links to relevant external information.
Benefit:
•	Process clarified and efficiency improved. IB process intranet site produced and ‘live’ within three months.
•	Positive feedback from customers on significantly improved IB quality.
•	On-line process support approach rapidly taken up by other R&D functions.

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Resource management and outsourcing

Issues:
•	The aggressive company growth strategy required a significant increase in investment in product development resource ¯ but the most suitable resource model for the company required definition.
Objectives:
•	Recommend the most efficient product development resource model to support the company’s business objectives including an integrated outsourcing strategy.
Services:
•	Given the group strategy, redefine core competencies and activities, conduct workload and resource modelling and assess potential outsourcing partners.
•	Develop an integrated resource and outsourcing strategy and support processes.
Benefit:
•	An integrated resource and outsourcing strategy making optimal use of current resource with the allocation of budget for strategic outsourcing.

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Training and staff development

Issues:
•	Internal and external audit findings suggested that Clinical training could be significantly improved. SOP compliance, understanding and interpretation were variable across different countries.
Scope:
•	International clinical SOP training strategy and programme.
•	Developing and delivering innovative SOP training courses.
Services:
•	Training strategy, planning and delivery of innovative interactive training courses on company SOP’s.
•	Delivery of ‘train the trainer’ programme for internal project management teams.
Result:
•	Over 100 people trained successfully, courses received very high scores on evaluation; number of courses and training audience expanded.
•	Client set up SOP review and revision forum following the success of training.

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