How can Sympto® assist you

Literature management

Use Sympto’s unique multi-tenant literature module.
Log everything related to the detection of relevant case reports.
Document a range of sources, from online to offline literature
databases and medical publications. When you find an article
or a case report relevant to more than one client,
you can enter it once or multiple times.

Literature management

Use Sympto’s unique multi-tenant literature module. Log everything related to the detection of relevant case reports. Document a range of sources, from online to offline literature databases and medical publications. When you find an article or a case report relevant to more than one client, you can enter it once or multiple times.

-

Our literature database is extensive and easy to
search through. Literature findings in Sympto® are
entered and grouped according to various criteria
(e.g. PSUR -relevant,  ­RMP-relevant). Managing findings is fast
and simple as the tool lets you create links between literature
findings and corresponding case report entries.

-

Our literature database is extensive and easy to search through. Literature findings in Sympto® are entered and grouped according to various criteria (e.g. PSUR -relevant,  ­RMP-relevant). Managing findings is fast and simple as the tool lets you create links between literature findings and corresponding case report entries.

How can Sympto® assist you

Client management

Use Sympto® as a client management platform by
composing reconciliation and activity reports. You
can generate an activity report that integrates all
pharmacovigilance-associated data entered in a
specific time period for a specific client.

Client management

Use Sympto® as a client management platform by composing reconciliation and activity reports. You can generate an activity report that integrates all pharmacovigilance-associated data entered in a specific time period for a specific client.

-

Our mail module allows you to track all sent
and received emails important to your client.
Sympto® lets you archive all of your inactive
clients, making your client list clearer
without losing any information.

-

Our mail module allows you to track all sent and received emails important to your client. Sympto® lets you archive all of your inactive clients, making your client list clearer without losing any information.

How Sympto® can assist you

Case reports

Case entries are based on the E2B-ICH(R3)
standard and their coding is MedDRA-based.
You can view every case in all standard formats.
There are several export options available such
as CIOMS form, Line Listing, Summary Tabulation
and Printable View. Use the Test Cases module to enter test cases,
send test safety reports and train new users.

Case reports

Case entries are based on the E2B-ICH(R3) standard and their coding is MedDRA-based.You can view every case in all standard formats. There are several export options available such as CIOMS form, Line Listing, Summary Tabulation and Printable View. Use the Test Cases module to enter test cases, send test safety reports and train new users.

How Sympto® can assist you

Safety reports

Case delivery is easier than ever now that it is
automated and in line with the requirements
of regulatory bodies (EMA’s and FDA’s included).
When it comes to ICSRs, Sympto® is compliant with
every regulation, directive, EMA’s GVP
modules and the processing of safety messages
and individual case safety (EudraVigilancelHuman).

Safety reports

Case delivery is easier than ever now that it is automated and in line with the requirements of regulatory bodies (EMA’s and FDA’s included). When it comes to ICSRs, Sympto® is compliant with every regulation, directive, EMA’s GVP modules and the processing of safety messages and individual case safety (EudraVigilancel Human).

-

The multi-client ICSR module provides
centralized reaction management and
exchanges data with third parties through the
EudraVigilance Gateway. To ensure your ICSRS
are ready for reporting, you can use the lock
option to make the case read-only and ensure
it cannot be further edited.

-

The multi-client ICSR module provides centralized reaction management and exchanges data with third parties through the EudraVigilance Gateway. To ensure your ICSRS are ready for reporting, you can use the lock option to make the case read-only and ensure it cannot be further edited.

How Sympto® can assist you

Signal detection

You can use extensive filtering options in the
module dedicated to case management. This
is very effective if you use the qualitative
method of signal detection and need to employ
various criteria to detect the potential signal for
the medicinal product at stake.

Signal detection

You can use extensive filtering options in the module dedicated to case management. This is very effective if you use the qualitative method of signal detection and need to employ various criteria to detect the potential signal for the medicinal product at stake.

-

Alongside the qualitative approach, Sympto®
also offers a quantitative signal detection
option which is in line with the latest European
requirements (ROR analysis). You can use both
methods simultaneously to get the most out of
your signal management, all in one place.

-

Alongside the qualitative approach, Sympto® also offers a quantitative signal detection option which is in line with the latest European requirements (ROR analysis). You can use both methods simultaneously to get the most out of your signal management, all in one place.

How Sympto® can assist you

Aggregate reports

With Sympto®, you have all of the materials and data you need for
writing common aggregate reports such as PSURs close at hand.
Filtering options can help you determine the articles you wish to use
in your medical writing. You can also retrieve valuable data by using
Line Listing and Summary Tabulation options which are essential in
assessing the potential risk of a certain medicinal product.

Aggregate reports

With Sympto®, you have all of the materials and data you need for writing common aggregate reports such as PSURs close at hand. Filtering options can help you determine the articles you wish to use in your medical writing. You can also retrieve valuable data by using Line Listing and Summary Tabulation options which are essential in assessing the potential risk of a certain medicinal product.

Contact us for more information

6 + 12 =

Quick Links