PV operations: Is e-mail the only way to organize your team communication?
Most PV processes are a group activity. Each employee of a pharmacovigilance department has a special role in the team, and each member is equally important for meeting the highest standards of compliance.
A PV team consists of multiple specialized roles, each requiring high levels of expertise, that in combination create the perfect formula for GVP. We’re talking about versatile teams of experts in various fields, working together towards a general end goal by focusing on their own individual tasks.
These tasks tend to be wildly different, and the way they all fit together is hard to perfect and maintain. So, how do you keep everyone perfectly in sync, without unnecessary setbacks or hurdles?
The answer is easy: good cooperation and reliable guidance.
Unfortunately, this is easier said than done. Day-to-day pharmacovigilance teamwork is often complex, abstract, and never repetitive. This makes smooth cooperation much harder to achieve.
But not impossible.
In our day-to-day experience, we have come to acknowledge the importance of clear and direct communication. And that’s why we have developed Sympto®, a PV collaboration platform that eases communication between team members and PV authorities they answer to.
We dug deep to analyse how collaboration ticks in a PV team. We analysed typical ways of communicating and how we can improve them. And we listened to feedback from experts on every position in the PV team, from trainees to the top of the organisational chart.
And now, we’ll share what we learned.
Communication within the team
Enhance communication from data entry to medical review
The information one member of the team transmits to another must be immediate and clear. Organising your PV activities through e-mail or remote project management tools seems like a completely unnecessary detour. Why wouldn’t we just use our PV platform for a more natural exchange of information? We could communicate directly through the system, without e-mails, right on the point of discussion.
We’ve put additional effort to make Sympto’s Dashboard, comments, and notification system to streamline various types of communication we’ve always needed to boost our everyday tasks. In Sympto® you can comment on findings, and case reports in any part of the process. It makes QC so much easier, as you can write comments directly in the section that needs fixing.
Literature screening and report writing are natural extensions of one another. And we believe we should make their connection more organic, so that these processes and the data they yield are synchronized.
Timely reaction is the backbone of compliance. Handing over the responsibilities must be immediate and built-up. There can be no risk of a colleague losing sight of a task in the heap of other obligations.
Get notified on time
We developed the Dashboard into a clear list that helps you keep an eye on any open tasks, and the status of the project you’re collaborating on. The delegation of tasks is perfectly choreographed between team members. And you can understand the list in just a glance. Urgent tasks must be visible, so they always appear on the top in a distinct red. Other types of notifications are all color-coded, giving the Dashboard a new, more intuitive language for communication.
But the tasks accumulate and sometimes your list becomes too long. That’s why we use filters that can sift through notifications and sort them by their nature, urgency, user, client… These options give you control over all tasks, open or closed, urgent or on hold. And nothing ever goes unnoticed.
Pharmacovigilance department communication
As the leader of the team, it’s very important to check on every member of your team. You must be aware of the workflows in your department. This is especially important for handling cases. Each case goes through many hands and different levels of the hierarchy, and each team member on every level must be completely aware of all actions made during the case processing. From case entry to QC, it is vital that every change is recorded and communicated clearly to all members of the chain. This also comes in handy with literature monitoring, as often the person screening databases isn’t the same person who uses the findings for composing reports.
In Sympto® you can easily communicate everything about a project directly in the system, right next to the item you need to comment on. The person who handles it will get an instant notification on their Dashboard or e-mail, enabling them to respond promptly, without ever having to leave the platform, or even the module they’re working on.
This is especially important to new employees and trainees. Provide them with all available materials that would get them in the loop as fast as possible. With Sympto®, you can also make sure they can always freely reach their more experienced colleagues when they find themselves in doubt.
Communication with clients and affiliates
Your work must be perfectly transparent and clean, like slides used on microscopes. It’s important that every letter you type is recorded and stored. Your client must be able to get a look into anything you’ve done for them, be it screening, reporting or communication with regulatory bodies. Free flow of information in both directions is the basis of trust between you and your client.
However, that flow of information is not a single, serene stream. It’s more like a torrential downpour coming in from every direction, and you need strong organization to control and comb through it.
Usually, information is collected in forms or spreadsheets prepared by the client. There is no universal model these documents follow, meaning you could have wildly different protocols for each client you cooperate with.
Sounds like there could be an easier way to do this, right? We thought so, too.
That’s why Sympto® tracks and records every step you take. It’s completely reliable, transparent, and easy to use. It serves as an audit trail for all relevant activities. It can also export reconciliation reports in a click giving your clients and affiliates information on all activities performed during a particular period.
We first developed the multiclient functionality in Sympto® for CROs to easily manage any number of clients they have, without unnecessary back-and-forth or repeating the same action multiple times.
This functionality also enables large pharma companies to efficiently manage their affiliates. No matter how branched out you are, or how many departments you have working independently all over the world, Sympto® helps compartmentalize as well as sort information and communication in a clear way.
Communication with authorities
Your internal communication reflects the communication outside of your organisation. Transparent communication is vital in maintaining trust with authorities – the leading currency of every pharmacovigilance department. Gaining it, however, requires orchestrated efforts. Sympto® enhances your trustworthiness with authorities with multiple features:
1. Drug safety data integrity
Sympto® offers system to system communication, cutting out any unnecessary steps in the workflow. The E2B R2 and R3 compatible workflow enables sending reports directly to AS2 gateways. Both the FDA and EMA are included, of course.
We believe that integrating PV workflow to one secure cloud database ensures there is a single source of truth to all data, import to output. By having the whole workflow adjusted to R2 and R3 standard, Sympto® guarantees the compliance of your data.
2. Verifiable activities
Daily activities such as literature search, processing, reporting and submission of ICSRs account for a large part of every PV organization’s schedule. That is why it is important that such large amounts of data are pristine and structured from every angle.
Sympto’s user-friendly interface enables a faster and more accurate entry of cases and findings. By notifying users of any incorrect information in completed fields, human made errors are quickly resolved. Ultimately, your report writing becomes more efficient and the process of authorization and QC is undertaken much faster.
Sympto® saves and tracks all activities within the system so that in time for audits you can transparently present all your work to the capable authorities in a click.
No matter the size of your organization, meeting deadlines is always a top priority. If deadlines are consistently met, authorities perceive organizations as a reliable and organized cohort, helping pass audits without stress. Therefore, how we manage deadlines must be taken into consideration.
Sympto’s Dashboard helps each team member perform activities on time. Not only does it help managers monitor work completed before the reportability deadline passes, it also automatically prioritizes workload for them. Notifications are presented in the colours green, yellow, and red, depending on their reportability date.
4. Risk management
The most crucial asset a PV organization has is its data. Due to the sensitive and personal nature of this data, we must take high security measures.
Sympto® encrypts data, arranges backups as frequently as you require and runs protocols that protect data traffic. By implementing a cloud system, you never have to worry about the safety of your data again. Trust Sympto®.
For further details on how data is stored with Sympto®, read our previous blog.
Communication with us
Pharmacovigilance is a field that always keeps changing and adapting. And our mission is to seamlessly adjust Sympto® to this dynamic. We upgrade the system continuously and with each regulation change, improving the system with new solutions.
Our supporting team is on standby to answer any queries or find solutions with a quick response rate. Get in touch with us and we will make sure to help you within 24 hours of your request. We always strive to find a more efficient way for doing things. And we develop our ideas from real, day-to-day experience of experts in pharmacovigilance.
And that doesn’t mean just our inhouse experts. We are open to hear all feedback from all our clients. As our client, you are free to share any ideas or suggestions for improvement you have. We’d gladly implement and test them. Our guiding goal in developing Sympto® was to make a PV platform that is naturally tailored to your work. With features that are instantly intuitive and user friendly. A tool that reduces any unnecessary legwork, leaving you the freedom to focus only on important tasks.
All these adjustments would never be complete without the experience and know-how of PV professionals. That’s why we encourage an open communication with everyone who uses Sympto® – your feedback is what helps us make pharmacovigilance more effective for everyone. Just write us a few lines or ask for our demo version to see for yourself.
Want to know more about this topic or about Sympto®?
We invite you to connect with us to make your audits and inspections easier.
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