Your Eyes and Ears For Safety Surveillance
We Understand Your Drug Safety Challenges:
- Does your CRO use a collaborative cross-functional approach to Drug Safety?
- Are your clinical databases configured for single-source data and reconciliation with your safety database?
- Does your CRO make the effort to present data in a logical and effective manner?
- Does your CRO follow a delineated, transparent process with regard to adverse event reporting?
- Does your CRO streamline the SAE reporting process, enabling you to put your focus on other study activities?Drug Safety
Alleviating the burden of study safety reporting for our Partners
ARG Drug Safety remains committed to stakeholders throughout the entire life cycle of a clinical study by remaining vigilant and conscious of patient safety and regulatory compliance. Our goal is to provide the best service possible to our sponsors and to relieve the burden of safety reporting. The characteristic that sets ARG Drug Safety apart is the human factor. With a customer service-oriented approach, we build relationships with our sponsors and strive to understand how they prefer data to be presented. Instead of a one-size-fits-all approach, we pride ourselves on adapting to individual sponsor conventions. The hallmark of the partnership with sponsors is communication, which manifests in deliverables that follow a logical path, as well as follow-up touch points.
Overall, ARG Drug Safety is scalable to cover a variety of studies (in terms of volume of SAEs) because of our experience and expertise. In-house, ARG Drug Safety helps form a close-knit network of functional partners including ARG Medical Monitoring, ARG Data Management, ARG Clinical Operations, and ARG Quality Assurance.
Internally, we have the IT tools to ensure safety activities are tracked (TrialVista’s Safety Metrics Tracker for case processing, query, submission and safety letter tracking) and in compliance with sponsor expectations and authority requirements. We embrace new technologies and consistently strive to improve the synergy and efficiencies between different applications and stakeholders, such as working with sponsors and IT vendors in streamlining SAE reporting mechanisms, which build efficiencies for investigative sites and downstream data quality improvements.
"We pride ourselves on finding workable, effective solutions for our sponsors and partners.”
“Our processes not only alleviate this burden from the Sponsor, but also ensure 100% Sponsor awareness of all things safety related during a study. From developing custom reporting forms and plans to maintaining oversight of all adverse event reporting and documentation, we are your eyes and ears for Safety surveillance.”
Main Drug Safety Offerings
End-To-End Case Processing Activities:
- Receipt and Triage of reportable events (SAEs, Events of Special Interest): rapid assessment of all new events, duplicate checks, and distribution of information to all concerned parties.
- Protected Health Information (PHI) and Personal Data (PD): we are the gatekeeper who ensures all source information received is either free of PHI/PD or is appropriately redacted before it reaches the sponsor or is filed in the Trial Master File.
- Narrative writing: ARG produces quality event narratives based upon pre-approved templates in close connection and oversight from the study Medical Monitory and sponsor.
- Safety Database entry: quality data entry of all relevant details to produce necessary report documents (e.g., MedWatch, CIOMS, E2B, custom or standardized listings and XML documents).
- Query Resolution: Drug Safety works with the sponsor to query the Investigative sites for all case processing needs and assists with monitoring of the clinical database to ensure accurate and consistent data points.
- Peer review and Quality Control: all Safety work undergoes quality control steps (including peer and MM review) even before being sent to the Medical Monitor or Sponsor for review.
- SAE/AE reconciliation: we monitor multiple forms of adverse event reporting, such as between the clinical database and safety databases (sponsor and/or ARG), to ensure accurate and consistent data points.
- SAE Coding: all DS team members are trained coders in both MedDRA and WHODrug platforms. The DS team also serves as cross functional coders for ARG Data Management clinical data systems.
Periodic Safety Reporting
from IND Annual reporting to DSURs, ARG Drug Safety is experienced in providing the data and generating the reports necessary to support these regulatory requirements.
Safety Management Plan Generation
Based on our global experience, we have produced templates for readily generating custom project safety plans. We also have the flexibility to support sponsor plan templates.
We can either configure your study in our safety database (Lifesphere Safety Multivigilance, f.k.a. ARISg) or given our experience with other platforms (e.g. ARGUS) and proprietary systems, have the flexibility to work in other systems as well.
Our own internal proprietary tracking application, Safety Metrics Tracker, tracks cases and queries and produces metrics for processing activities.
The ARG Difference
Close Working Relationship with Medical Monitoring
As compared to other CROs, we are a tighter knit group with a higher Drug Safety to Medical Monitoring ratio. The result is we naturally work more closely, frequently and directly with both internal and external MM vendors, which in turn produces a more cohesive and effective product for the Sponsor.
No Single Staff Assignments
ARG Drug Safety follows a centralized team approach in providing safety services. Instead of a single representative on a given study, multiple individuals will be acutely aware of the needs and events of each study. In turn, this benefits the sponsor by having multiple persons available to answer questions or take action when necessary. We accomplish this by using frequent internal communication, as well as shared workflow processing, tasks, and responsibilities.
EDC Database Configuration for Safety Vigilance
ARG DS has both pioneered and worked with IT vendors on establishing new means of SAE notifications and reporting, such as developing EDC systems to also serve as the primary means of SAE reporting. By utilizing the EDC database for SAE reporting, ARG DS has reduced safety reporting burdens on investigative sites and ensured consistent and accurate information by eliminating outside data collection mechanisms (e.g. electronic or paper reporting forms). ARG has also successfully built SAE notification queries to provide immediate notification of the entry of qualified events (e.g. SAEs, Events of Special Interest) to ensure the appropriate and timely reporting by sites through the proper means for a given study.
Proprietary Safety Tracking Mechanism
ARG’s Safety Metrics Tracker (SMT) application (within TrialVista) is a single means to document all safety case activities across all studies. The application has the flexibility to host a variety of sponsor needs and wishes (e.g. whether or not ARG retains the safety database for a study) and provides a universal platform and a core means of managing all our studies’ activities. CROs of all sizes have means of tracking safety actions, but not all will have an independent means to track activities, proactively forecast and remind users when actions are due; in addition, ARG has the means to produce internal metrics reporting.
Cross-functional Safety Communications
Utilizing ARG’s TrialVista, ARG DS has the capability to ensure cross-functional partner awareness and responsiveness. For example, applications can prompt CRAs to ensure site activities are performed or can provide access to CRA site visit calendars. These technologies support communication between DS and site monitors to ensure site level communications and follow-up on outstanding and ongoing issues. These are hallmarks of not only our proprietary technology, but also speaks to the connectedness of our study teams.
ARG DRUG SAFETY
Uses Innovation in Two Trials, One Sponsor
In addition to helping meet the regulatory requirements and maintain Good Pharmacovigilance Practices (GVP) for safety reporting in clinical trials, ARG can also help facilitate the unique needs of each of our clients. We recognize that each company has its own unique set of internal resources and needs. One of our valued sponsor clients requested that ARG provide data for the Data Safety Monitoring Committee for two trials, not in the form of standard listings and SAE narratives, but instead in an innovative fashion that would be much more efficient in portraying the sequence of events for each trial subject.
ARG proved its flexibility to fulfill these needs by transforming what was a complex matrix of SAEs experienced by each subject over the span of the trial, into a series of concise, truncated summaries. Through the diligent work of ARG’s Safety team, chronologically referenced, sequenced, and comprehensive “SAE stories” were the result. ARG went beyond simply providing data listings or individual SAE narratives by providing a much more profound story for each subject. These summaries in turn enabled the external parties to more readily understand and assess the sequence or progression of events experienced by the trial subjects.
The highly regulated and structured world of Pharmacovigilance doesn’t always lend itself to creativity. However, in this particular example, we were able to develop a means of rapidly relaying high-level details from what otherwise would be a tangled web of individual events, into a very consumable format. Every sponsor has its own unique practices and conventions–ranging from simple things, such as preferred date formatting or document naming conventions, to producing highly customized reporting mechanisms and new approaches for presenting safety data. ARG Drug Safety provides individualized customer attention and solutions based on study-specific circumstances.