Data exchange can be one of the biggest challenges impacting relationships between CROs and sponsors. How does your company overcome this issue and what standards of practice can be followed to mitigate issues?
Data exchange is a part of the much broader issue of confidentiality when contracting R&D services. In reality, regardless of the geographic region to where services are implemented, the moment work is sent outside of the home office, confidentiality is potentially compromised.
DEL BioPharma LLC works with many clients some of whom are tolerant to perceived risk and some of whom are so concerned that they will not outsource to Asia or India. From a practical point of view and regardless of the geographic region utilized for contract services, CROs and CMOs would not be in business if there were significant violations of confidentiality. That having been said, sponsor companies should always take steps to minimize any risk to their programs. Such steps, applied to chemistry research and development, include the following:
- For medicinal chemistry, contract labs used for the preparation of target compounds should be separate and distinct from contract labs used for the assay of target compounds. The rationale behind this strategy lies in the fact that a CRO generating target compounds does not need to know what the target compounds are used for. Similarly, contract labs providing assay services do not require the structural identity of compounds under evaluation.
- For API manufacturing, separate contract labs should be used for the regulatory starting materials and for the final drug substance. The rationale behind this strategy lies in the fact that the manufacturer of the regulatory starting materials does not require knowledge of the final drug substance. Similarly, the manufacturer of the drug substance does not require knowledge of the process utilized for production of the regulatory starting materials.
In all instances, effective communication of sensitive information (batch records, analytical data/methods, patent applications, regulatory documents, etc.) is required in order to facilitate tech transfer, troubleshooting and overall project advancement. Aside from the fact that much documentation is so large that email transmission is ineffective, unless encrypted, there is some risk associated with email. As an alternative, there are many options for encrypted cloud-based data transfer. Unless an alternate platform is required by a given client, DEL BioPharma LLC uses ShareVault as a secure and encrypted platform for all document transfer between client companies and contracted laboratories.
In summary, there are many effective strategies and platforms for risk reduction associated with data exchange. The approaches described above are very effective in maintaining security and confidentiality in our current globalized pharmaceutical research and development industry.
By: Dan Levy, DEL BioPharma