Spido Technologies

Spido Technologies is a trusted global drug safety and pharmacovigilance services partner offering safety services to biopharmaceuticals for drug, device, vaccine/biologics, and cosmetic products. We provide a one-stop solution and services for the management of adverse events, SUSARs, ICSRs, CIOMS, MedWatch and other regulatory required formats emerging out of clinical trials and post-marketing surveillance.

Our highly skilled global safety team, work in the way pharmaceutical companies have handled drug safety requirements to be compliant to the regulators. Case management procedures at Spido Technologies follow in-house methodologies created by our talented QA professionals. We work with systematic procedures by simplifying tasks with detailed workflow through which we can provide high-quality output and effective services at an affordable cost.

As a drug safety services provider, Spido Technologies aims to meet all your pharmacovigilance requirements both at the clinical stage and post-marketing.

Individual Case Safety Report (ICSR) Processing

Handling of serious and non-serious reports from all sources.
Intake->Triage assessment->Data Entry->MedDRA coding->Narrative writing-> Medical review->Quality review-> Submission ready-> Submission to FDA handling- systematic tracking, versioning and follow-ups.

Adverse Events (AE) Case Management

AEs managing for cases arising from different sources.
AEs screened from spontaneous reporting in the post-marketing surveillance, case reports from clinical trials, and published literature searches.
Data Metrics, dashboard reports, and visualization.

Aggregate Reports- Prepare and Publish

Our expertise medical/regulatory writing team develop:

Periodic safety reports for global regulatory authorities- PADER, PSUR/PBRER
Offering writing support for ASR/DSUR
Provide medical review support for other vendors written aggregate reports
Adhoc and/or Addendum reports
Summary Bridging Reports (SBRs)
Drug Safety Reports (DSRs)
Development Safety Update Reports (DSURs)
Annual Safety Reports (ASRs)

Signal Detection

Signal Detection is a complex area within pharmacovigilance services which requires a high level of professional work. At Spido Technologies we address this challenge adeptly. We systematically, precisely track and document all special medical events that establish a signal for medical attention. Our PRR Statistical process includes:

Assessment Strategy- Routine and proactive AE Data mining
Screening, identifying, grading
Validation and Confirmation
Tracking and Trending
Analysis
Event Prioritization
External data search and comparison
Analysis and report
Recommending action

Risk Management Plans-Write/Update/Maintain

Our expert team of medical doctors has strong experience in developing

REMS – Risk Evaluation and Mitigation Strategies (For US FDA)
RMP – Risk Management Plan (for EU)

Digital Pharmacovigilance

With the onset of advanced technology to circumvent manual data entry errors, and speed up the decision, we are in the process of ratifying and enhancing our technologies to assist automate safety data entries from all possible safety data formats into the Databases. We work with industry best PVAI experts to help safety data is accurately and naturally captured for better decisions. Through this, we provide accurate, real-time, quality data entries for further assessments and decision making.

Our team of PVAI experts, programmers, clinical data management experts, medical professionals, drug safety experts, aggregate reporting scientists, and medical affairs personnel with our base of operations out of Princeton, New Jersey, in the United States and global delivery centers in Europe and India.