This service is aimed primarily at small pharmaceutical companies who have the ability to research a new molecule but lack expertise in pharmaceutical development. A major component of this service is the design and implementation of the preclinical programme and its integration into the overall development strategy.

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Although mainly required by small pharmaceutical companies, this service has created significant interest among the larger, more established companies who have worked with CROs for many years. This is a reflection of the continual changes in CRO performance, the increasing complexity of studies being outsourced and the demands from the pharmaceutical sector for improvements in CRO performance.

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Many companies now select this service as a cost-effective means of supporting limited in-house resources. 

In the past outsourcing was regarded as a relatively easy option, but in recent years the process has become more complex due to major advances in the scientific and technological aspects of toxicology and the strict demands of GLP and animal welfare.

With considerable experience of both the pharmaceutical and CRO industries, APC are ideally positioned to provide this support to clients.

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This service is a natural extension of monitoring studies at contract.

One problem common throughout the pharmaceutical industry is the lack of internal resources to review CRO reports promptly.

APC are experienced in reviewing the full range of preclinical study reports and in discussing findings with the sponsor and author in order to expedite completion.

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Writing and reviewing toxicology reports is often a rate-limiting step for many drug companies. This situation is set to worsen given the dual pressure of management requiring shorter times to market and the discovery technologies such as proteomics, combinatorial chemistry and high throughput screening providing an increasing number of candidates for development.

One practical solution is to outsource report preparation and review. Indeed many of our clients have already found this to be a ready-made solution for their problem.

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This service is almost exclusively used by small drug companies with limited expertise in dealing with the regulatory agencies.

By discussing a single issue or presenting a programme of work to the authorities, APC have been able to help clients avoid costly problems later in the development process.

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Drug development is a highly complex, multi-disciplinary business, so when questions arise outside our areas of expertise, APC have a network of independent associates on whom we call. 

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APC have experience in preparing dossiers for international regulatory agencies.

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A major feature of the pharmaceutical world is the in- or out-licensing of drugs in early development. The considerable financial investment involved necessitates a thorough and competent review of the data. An APC analysis includes reviewing the dossier for completeness, technical competence and scientific content and highlighting any areas of concern. We provide the sponsor with an assessment which would indicate studies which may need to be completed or repeated and an evaluation of any likely contentious issues.

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Workshops we have conducted alone or together with other consultants include report writing, reproductive toxicology, inhalation toxicology and strategies for preclinical outsourcing.

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APC’s extensive management experience in the CRO industry forms the basis of a range of services companies can access to improve their business. These include:

• Objective evaluation of a company, division or department with the aim of improving efficiency.
• Advise on business opportunities in a rapidly changing market.
• Critical, independent evaluation of a facility as a part of the assessment prior to acquisition.

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Both the CRO and pharmaceutical industries are continually evaluating the potential for growth by acquisition. The objective assessment of a facility, including its staff, is a critical part of this process. APC are well-positioned to offer an independent, critical assessment which is detached from the often subjective perspectives within a company.

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