The SDEA, or PV Agreement, is at the heart of all pharmaceutical business collaborations. Contractual arrangements with other companies are used to advance the development of, or expand patient access to, licensed products. These agreements detail the exchange of safety-related data between the companies and are used to fulfil regulatory reporting obligations, ensuring awareness of potential safety considerations for all parties.
Whether your company is licensing a product to a new region, a CRO is running a clinical study on your behalf or a marketing agency is managing an initiative for you, any and every business interaction with another company, partner or affiliate will need an agreement. The agreement acts as a mutually approved obligation to share any safety data gathered.
Streamlining and automating the Agreements process
Historically, like so many PV processes, agreements were a heavily manual procedure. Large word documents were laborious and time consuming to create. One party started the agreement, followed usually by an internal review, a review by the second company, more reviews and amendments and then, hopefully, sign off. Only then did the agreement become legally effective. It was a long paper process. Once signed, these agreements would usually be held by the legal departments in document management systems, so it was not always easy for PV staff to have quick access or to have a thorough overview of agreements in place.
HALOPV’s module enables the whole agreements process to be quicker, easier and more efficient. By automating the creation of the agreement with easy-to-use templates, the agreements workflow takes far less time and the content is structured. Questionnaires can be configured to tailor the agreement text to specific situations. Additionally, reminders can be set up to prompt reviews after certain periods of time so that any changes in the relationship are noted; the partnership might have ended or perhaps the regions have expanded? The agreements must be kept as up to date as possible and by creating appropriate triggers, they can be checked as regularly as needed.
Integration and transparency within HALOPV
One of the key features of HALOPV and its 18 modules is integration between the modules and the state-of-the-art technology that is used throughout. For the Agreements module, not only does it auto-generate the SDEA documents and include electronic signatures for fully digital workflows, it also links to the PSMF module to populate Annex A, B and C and to the Requirements Intelligence module so that all partner obligations are kept up to date with global requirements.
Important for all, large or small
For smaller companies, the Agreements module can create agreements with ease and allows for an effective overview of partnerships and affiliates. However, for larger companies, it is even more important. With offices or divisions often spread across the
globe and with a vast number of agreements per office, the opportunity to have a transparent view all agreements, with an audit trail for all changes and updates, is of paramount importance.
So, why not create a streamlined and automated process for your agreements? Take a look at the Insife solutions and then all your agreements can be safely housed under one HALO roof.
We would love to tell you more and answer any questions you have, take you through a demo or let you test the system so you can explore yourself. Just email hello@insife.com.
We look forward to working with you.
