AE SignalAE Signal

The Situation

Assuring patient safety across the product lifecycle is imperative in life sciences. Concurrently, biopharma and MedTech companies are experiencing tremendous urgency to deliver and maintain products while improving cost and efficiencies.
>20%
annual increase

in reported adverse events

70%
of budgets are spent on

case processing and reporting

The Challenges

The key to your success is automating, adopting advanced technologies, and leveraging insights that improve compliance, product safety and add value to your product development process.
Growing safety workloads, geographic expansion, and regulations.
Sharp increases in the complexity of managing adverse events.

Legacy solutions are aging and don't scale to meet new challenges.

AE Signal
Conversational Real-time AE detection & review:

Quickly detect adverse events through online/Conversational IVR discussions. Our AE Signal solution is a complete toolset for assessment, routing, and documentation.

AE Signal solution combines the best of technology and human agents. AE Signal tool automatically reviews, categorizes and identifies adverse events to bring them forward.
Detect : Automatically detects AE and other Potential Technical Product Information in Structured and unstructured Data during the course of conversation either beginning of the conversation or end of conversation IVR.

Collect : Identify the AE during the course of Conversation and matches with MedRA dictionary and entities, synonyms and transfer to Human Agent at any point and shares the Transcript and recording.

Intake : Automatically allows intake of AE from external and internal Sources using NLP ,AI and ML.

Signal: Automatically identify real-time signal detection for Proactive, adaptive safety surveillance and risk management across diverse data sets.

Reporting: upon identifying and signaling the AE it will highlight and request the user if he is interested to talk to a Human agent and shares the transcript and recording as an email highlighting the AE.

AE Identification & Reporting

Why choose us?

We strongly believe in CO-Innovation/Collaboration/Investment behind Plug & Play Technology. Once you come, we will build long-term relations with you and your personal interests, caring about and piquing genuine curiosity about your end-user’s lives.
Empathy
Awareness
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Familarity

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Education
Consideration

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Emotion
Decision

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Advocacy

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Patient Journey

Patient Journey and Capabilities

Activation & Awareness
  • Diseases Education Awareness
  • Medication training/Coaching, Communities together ( similar Diseases)
  • Pre/ Infusion/Post Infusion services
  • Symptom Tracker
  • Registration / Single Sign On
  • Approval of user activation to access portal.
Patient Program & diagnosis
  • Consent/ SRF/Terms and conditions Management
  • Adherence program enrolment
  • Scheduling appointments
  • Connected Health ( Device Apple, Alivcor, fitbit, Sleeping devices etc.)
  • Health Data (EMR) integration
  • Self Diagnosis
Treatment
  • Benefit Verification
  • PA, Bridge Program
  • Financial Assistance program
  • Free Product./Delivery support
  • Co-pay, Coupons/Vouchers
  • Financial Assistance program
  • Call Center Operations
  • Adherence Program
  • Reminders
Post Care & Co-ordination
  • AE Reporting
  • OMS
  • Patient engagement/Monitoring (Post Infusion)
  • HCP Specialists Care Co-ordination
  • Patient Communities
  • Connected health
  • (Eco-system i.e Registered Dietician, Physio, Cario, etc)
MicroGrid (& for its products) has established a QMS following GAMP 4 & 5 practices, adhering to GxP processes, is Global ePA (Privacy Assessment) certified meeting the local DP laws, conforms to Risk & Compliance Policies, and has implemented 21 CFR Part 11 Governance and Documentation.
Industries

Health Care

health-graph
Digital medicine uses technology to help make the care you receive better by collecting more health data than was previously available. Many digital medicines provide personalized information to either healthcare providers or consumers. This information can then be used to guide treatment decisions or potentially suggest medication dose changes.

Examples
  • Digital Medicine includes evidence-based software and hardware products that measure and/or intervene in the service of human health.
  • Requirements for regulatory oversight vary. DM are classified as medical devices require clearance or approval.DM products used as tool to develop other drugs, devices, or Medical products require regulator acceptance by appropriate review division.
These DTx products may be something that you can buy on your own — like an over-the-counter (OTC) product — or that your healthcare provider prescribes to you. Prescribed digital therapeutics (PDTs) would be similar to a medication that you take. But instead of going to the pharmacy for refills on medications, it may be an app or device that you use and your provider can remotely monitor to see if it is helping you

Examples
DTx are still relatively new and undergoing clinical testing. But several are on the market, including:
  • An app that can help people with Type 1 or 2 diabetes manage their condition and help guide insulin dosing
  • An app that uses AI to help people with depression overcome negative thoughts and behavior over a 12-week treatment period with one to two 30-minute sessions a week
  • A app that helps with muscle pain by using your smartphone’s camera to help guide you through physical therapy and provide feedback on your progress
Digital health includes Lot of benefits technology that you may already use, such as:
Benefits
  • Improving communication with your healthcare provider
  • Sharing health data (e.g., blood pressure, blood sugar, temperature) with your healthcare provider from home instead of waiting for an appointment
  • Helping healthcare providers better customize treatments and healthcare decisions
  • Making healthcare providers and services more accessible for people
  • Lowering healthcare costs
Examples
  • Telehealth platforms
  • Exercise and diet apps
  • Medication adherence apps
  • Meditation and mindfulness apps
  • Fitness trackers that measure how far you walk or how well you sleep
  • Smartwatches that track health vitals (e.g., heart rate, blood pressure)
Digital Disease Management
Digital platforms that help patients with chronic conditions or help with prevention
Consumer Digital Medicine

Products and services ordered and paid for by consumers (e.g., “wellness apps”)

Digital Diagnostics

Digital products that clinically diagnose or facilitate a diagnosis, often assisted by AI

Digital Component

A digital element of a previously existing drug or medical device

Prescription Digital Therapeutics (DTx)

Digital therapies prescribed to treat a medical condition

Integrations

Partners

Use Cases

Stay Tuned