Regulatory Compliance

Regulatory and compliance requirements are growing for companies trying to introduce a new medication. Sylogent develops software solutions that help automate many of the tasks in the compliance management process.

SYQUENCE delivers the right tool each individual needs to complete their tasks in the most efficient way. SYQUENCE, designed specifically for the life sciences industry, centralizes your regulatory information to help you promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product releases, and operate and compete more effectively worldwide.

SYQUENCE is a cloud-based system that is instantly accessed from any computer that has internet access. Configuration for new clients takes just days and includes many preconfigured out-of-the-box forms, templates and workflows.


Optimize your resources!

Increase Productivity

62%

Increase Collaboration

83%

Improve Compliance

100%



We were wasting over 30% of our time just looking for the data. SYQUENCE enables our people to spend their time doing research.


Regulatory Compliance Solutions

PROJECTIC is a revolutionary tool that is easy to use and less expensive than MS Project. Just push a button to import studies from any source and PROJECTIC will automatically visualize the study timeline. The configurable PROJECTIC rules engine can automatically create regulatory milestones for each study and create the project template for the required work.
The SYQUENCE Approvals Module (SAM) is ideal for every regulatory and or compliance group that is currently using email to route information for approvals or clearance. The module allows for clients to use out-of-the-box Decision Matrix, Forms and Workflow configurations or client specific configuration. SAM has been deployed at three of the top five pharmaceutical companies and was even launched with zero training at one.

SAM is also integrated with our client branded Clinical Study Register product for those companies seeking to share their Protocols, Clinical Study Reports, Results Summaries, Publications and other study information with the general public.
The VCTR ( VICTOR ) module is currently configured with the regulated US Protocol and EU Clinical Trial Application (EU CTA) forms that must be submitted during the registration process. VCTR also has the US Results and EU Results forms that must be completed for many studies after the completion of the trial. VCTR is configured to reuse data from your CTMS or SAS databases by automatically pre-populating the structured forms in VCTR via an XML data feed. Each form has a unique configurable workflow so that review and approval is fast and efficient. Just push a button to upload the approved records to your ClinicalTrials-gov account or export to upload ready XML for EU CTA registration.

VCTR, like SAM, dynamically publishes data to an optional client branded Clinical Study Register for those companies seeking to maximize their transparency efforts.
Governments, advocacy groups and medical professionals have requested more transparency from companies that are sponsoring clinical trials. The SYQUENCE system includes an integrated Clinical Study Register (CSR) which is a public website with up to date information on the study. The CSR dynamically publishes information such as Protocol, Results Summary, Clinical Study Reports and publications from SAM and VCTR after the approval process has been completed.

Each study has a unique landing page so that your study information is easy to find and professionally displayed.
SYQUENCE offers a centralized place to manage your document templates so they are instantly available and easily accessible to appropriate individuals. Our propriety document builder allows for easy reuse of previously approved information in a simple drag and drop interface.

Just push a couple of buttons to instantly share a document or template directly from SYQUENCE.
Resource management is optional functionality available in SYQUENCE. The configurable nomination form is sent to the Approvals Module by clicking a button where it routes through the preset workflow. After the nomination process is completed, just upload your approved contract template and automatically send a data merged PDF to your healthcare professionals with the push of a button.

Training modules can be sent to individuals directly from SYQUENCE. When each individual has completed their required training the system can instantly generate a personalized certificate.
SYQUENCE manages data from a variety of external sources including public websites. Just push a button to see your up-to-date compliance report and study metrics for ClinicalTrials-gov. The dashboard also includes access to all of your competitor's information categorized by condition and or study phase.

SYQUENCE also displays authors and their top collaborators from PubMed with the push of a button.

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Integrated Modules

PROJECTIC

project planning and tracking

SAM

information ( documents + data ) approvals and clearance

PUBSTRAT

journal, conference and author selection + publication project management

VCTR

US + EU protocol registration and results disclosure

SYQUENCE

data, templates, resources, & documents management

CLINICAL STUDY REGISTER

study information public transparency website