Outsource according to core competencies
the most important things a sponsor should do is define its core
competencies and then outsource accordingly.
Surprisingly, many companies fail to do so, delegates heard from Anne Maria Ylisaari, head of In- and Outsourcing at Orion Pharma, during a presentation at last week's "Outsourcing Clinical Trials" conference held by SMi in London.
"Core competencies should always be defined in order to ensure harmonisation among different studies and projects," she said.
Functions that Ylisaari believe should be deemed as core by a company and kept in-house include trial planning, design and writing of the outline, designing the case report forms (CRF), writing the monitoring plan and statistics.
Regulatory applications, quality assurance audits and maintenance of the serious adverse event (SAE) database and reporting of SAEs to authorities, in addition to SAE/AE medical review and coding were also listed.
However, the data safety monitoring board should always be outsourced, she stressed.
Meanwhile, functions that should be outsourced wherever possible include protocol writing, feasibility study, printing of CRFs and consultancy on the protocol design, regulatory submissions and recruitment plan.
In regards to the site, aspects such as site selection, monitoring and management, collection of site documents, study supplies and logistics, as well as site initiation and closeout can also be outsourced.
Other aspects like investigator and clinical research associate (CRA) travel arrangements, managing vendors, medical writing, data entry and archiving should also be considered.
"Most of the outsourced elements should always be kept in check by an in-house project manager whose job it is to maintain the communication lines between the two firms," said Ylisaari.
"If some of these activities are only partly outsourced, the lead role should then be the sponsor's, enabling data to be integrated with less effort, shorter time and reduced costs."
