Outsourcing (BAM: BioAnalytical Monitoring)
Having worked with both pharmaceutical companies and CROs, we are ideal partners for you to establish your efficient and successful partnership with CROs. We have recently published: “Bioanalytical outsourcing – the two sides of the medal.”, Bioanalysis (2013) 5(17), 2095–2099
We offer:
- Development of outsourcing strategies, i.e. in which stage of drug development to outsource which type of studies, to where and to whom
- Evaluation, audit and selection of CROs
- Inquiry, review and negotiation of offers
- Preparation of work orders, contracts, master service agreements and other
- Monitoring and tracking of outsourced projects and studies
- Review of study protocols, data and reports from CROs
- Check of compliace with current regulatory requirements
- All communication, e.g. with CROs, central lab, project leaders, CTLs
We recommend only CROs which we have audited and which are best suited for the purpose of your projects and requirements, i.e. CROs which:
- Got an excellent scientific and regulatory reputation
- Meet all current regulatory requirements and did not have any major findings during audits
- Are communicative, responsive and interactive, and don`t waste your time
- Deliver on time and with high quality of analytical work, data and reporting
- Are innovative and offer state-of-the-art science and technology
- Achieve and assure robust assay performance even at very low LLOQ
- Are able to handle large sample numbers in the lab and in data work flows
- Offer a fair price/performance ratio
- You are in dispute in-house, with your clients or CROs, due to implausibility of data, unexpected mismatch with historic data, potential deviation from guideline requirements and so on.
- You do not have yourself the required background to evaluate or judge data you have received from your contract partners.