Case Study 1 - helping Japanese clients become more effective in Europe.
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Japanese companies are increasingly developing their pharmaceutical compounds outside Japan. Many of them strategically choose to outsource the drug development to a global or EU-based contract research organisation (CRO) to conduct the studies on their behalf.
Outsourcing of clinical trials is a relatively new phenomenon in Japan and many companies want to avoid the common mistakes and pitfalls that this represents.
A leading Japanese pharmaceutical company asked ADAMAS Consulting to help them evaluate and select a European-based CRO to develop one of their leading compounds.
After a thorough analysis of the company’s needs ADAMAS Consulting were able to produce a tailor-made programme that enabled the company’s key Japanese personnel to evaluate and select a CRO with confidence.
Case Study 2 – due diligence and understanding client needs
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Many healthcare companies have taken the strategic step to in-license and out-license pharmaceutical compounds. These compounds can be at various stages of the drug development programme. One of the key things that companies are trying to do is manage the risk involved in such activities.
A leading US-based biotechnology company wanted to in-license a drug compound in the late stages of development. They were keen to adequately manage the risk associated with the on-going clinical development programme. They wanted to know what they were buying. Were the studies being adequately conducted or would some need to be repeated?
The company asked ADAMAS Consulting to undergo due diligence of the clinical studies and provide recommendations on the conduct and quality of the studies with respect to international regulatory standards.
Understanding the needs of the client, ADAMAS Consulting successfully completed the due diligence of the compound and reported back. The findings helped the company make a go/no-go decision on whether to proceed with the agreement.
Case Study 3 – clients want a trusted and experienced team
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The governing body of a group of CROs requires that their members are independently audited on a regular basis to ensure that they meet the quality standards established by them.
Based on our track record and experienced team, ADAMAS Consulting was invited to be the independent auditor to conduct the quality audits, on an on-going basis, on each member CRO. This involves a rolling audit programme and requires excellent planning and coordination. The programme has been successfull and is still continuing. Several of the CROs now advertise the fact that they have been audited by ADAMAS Consulting in their proposals.
Case Study 4 – rapid response to an urgent need with a skilled team
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A multinational pharmaceutical company had suddenly discovered a major issue with some of their laboratory results in a clinical study. They quickly contacted ADAMAS Consulting asking us if we could urgently schedule several audits throughout Europe within the following week. Furthermore they required that the audits be completed within three weeks.
ADAMAS Consulting was able to respond quickly and flexibly to schedule the audits such that the client could meet their very tight deadlines. Even working to such deadlines, ADAMAS Consulting was able to identify key issues very quickly. Corrective actions were recommended to the client and these were satisfactorily implemented immediately.
Case Study 5 – specialist services, a competent team and a happy client
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A multinational pharmaceutical company required specialist services and high competency levels to advise on a potential regulatory inspection of their clinical computer systems. Their anxiety levels were extremely high!
With our highly skilled and competent team, ADAMAS Consulting were able to pacify the client and carry out the necessary work. ADMAS carried out a gap analysis, which highlighted major areas of non-compliance. In addition, ADAMAS Consulting produced a practical and pragmatic action plan and provided continuing advice and help. Furthermore, ADAMAS Consulting assisted the client in recruiting the necessary, experienced staff that would be able to manage their clinical IT requirements.
Case Study 6 – a motivated team working for the long-term
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A global, well-respected, leading, major pharmaceutical company asked ADAMAS Consulting to help them perform a two-year audit programme on a (large) (18,000) patient outcome study involving many sites throughout Europe.
The client required a skilled and competent team of auditors that they could rely on over the two-year period. Owing to the high skill competency, the ADAMAS Consulting team were able to identify inconsistencies in the study at an early stage. These inconsistencies were only noticeable by the fact that the team were able to collate and assess their finding across all the countries.
Case Study 7 – Pre-inspection Assessment of Pharmacovigilance Systems
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A top global pharmaceutical company requested a comprehensive assessment of pre- and post-marketing pharmacovigilance activities in its European headquarters and UK affiliate company. In addition, an audit of the role and responsibilities of the Qualified Person for Pharmacovigilance (QPPV) was required.
The assessment was conducted over a three-week period by a team of experienced ADAMAS Consultants, including a pharmacovigilance expert and QPPV. The combination of experienced pharmacovigilance auditors and a pharmacovigilance expert ensured that the assessment identified key gaps in pharmacovigilance systems, and that pragmatic and effective recommendations for improvements were made.
The company received the assessment report very positively and implemented many corrective actions before the inspection. For those corrective actions that required a longer implementation period, a plan of action was prepared which was acceptable to the regulatory inspectors.
Case Study 8 – Mock GCP Inspection
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Conducting a mock GCP inspection before a scheduled inspection is an invaluable experience for the personnel involved in the inspection. ADAMAS Consulting is frequently asked to perform such mock inspections.
A mock GCP inspection was recently requested by a specialised global pharmaceutical company at their headquarters. ADAMAS Consulting inspectors were requested to make the experience as realistic as possible, including announcing themselves as inspectors at Reception! Three mock inspectors were involved, and they each inspected different parts of the Clinical Development function, thus maximising the complexity and resource requirements of the mock inspection.
Mock inspections require significant preparation by both the company and the mock inspectors, and a detailed inspection plan and agenda must be prepared at an early stage to ensure that all necessary personnel are available for interview. A close collaboration was developed between the Lead Mock Inspector and the QA Manager of the company to ensure the efficient conduct of the mock inspection.
The mock inspection took three days and involved interviews with approximately 30 people and review of hundreds of documents. The inspection findings were presented in the same format as a regulatory inspection report, however a supplementary report was provided which gave feedback on the company’s performance and recommendations for improvements before a real inspection.
The company managed the inspection as if it was real with a war room, document tracking systems, scribes and runners. Although such an exercise has a significant impact on resources, the company found the exercise very worthwhile and it gave them confidence that they would be able to manage a real inspection very efficiently. The mock inspection was very intense for all concerned, but it was considered a worthwhile experience, the mock inspectors even received applause at the close-out meeting! This may not happen in a real inspection though!
Case Study 9 – Quality Management Systems Review
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A medium-sized global pharmaceutical company requested ADAMAS Consulting to review its Clinical Operations from planning to reporting in order to identify gaps and areas of non-compliance with internal procedures and regulations.
Detailed audit plans were developed for each stage of clinical development that were being reviewed i.e planning, conduct, data management and biostatistics, and reporting. Three studies at different stages were used to follow the processes through during each audit. As with all systems audits, success depends on the level of preparation. This requires a review of all applicable SOPs, development of a detailed audit plan and agenda.
The systems review was conducted in three stages with two consultants spending between 3 and 5 days on each stage. Separate reports were produced for each stage to enable the concerned groups to focus on their own corrective action plans.
The company found the review valuable and enabled it to improve its quality systems to ensure greater efficiency, as well as regulatory compliance, in the conduct of its clinical trials.