HLMS - HAROM'S LITERATURE MANAGEMENT SYSTEM

What? What is the Process

SEARCHING & SCREENING

HAROM Solutions has developed the procedures to ease the case processing and handling of literature data and our services include:

  • Screening and Extraction of Literature cases
  • Monitor safety-relevant literature databases like PubMed, Medline, Embase etc.
  • Rapidly identify adverse events from wide range of sources like:
    • All relevant international journals
    • 100 major scientific meetings
    • Newsletters
    • Regulatory agency websites
    • Media releases

CASE CATEGORIZATION (TRIAGING)

Expedite the promotion and processing of reports through upfront triage in the inbound workflow. The experts assign one or more categories for each search result according to the information related to Seriousness and Expectedness of the case taken from the title, abstract and key words.

  • Expedited cases: Serious and Unexpected cases
  • Medically Significant cases
  • Non-Expedited cases
  • PSUR relevant cases: Non-valid cases but with important safety relevant data to be included in PSURs.
  • Other cases

CASE PROCESSING IN HAROM SAFETY SUIT

HAROM case processing include following steps:

The first step in entry of case in HAROM involves duplicacy check. The Duplicacy Checks are carried out against local receipts as well as cases promoted to safety database.

Structured standardized data entry early in the process ensures improved data quality along with System supported validations to ensure correct and complete entry.

Drug safety data is prime importance to the MAH and regulatory authorities. So quality of data matter a lot. To keep this in mind our organisation has set up two quality checks

Whenever client needs cases for a specified drug the administrator generates reports from HAROM

How? How ICSRs will be Delievered
Refine search strategy to capture all ICSRs related to the molecule.
Tracking system to avoid duplicates reviews of same articles
Well defined automated system for article screening process.
Trackers maintained at all levels of screening and review process
Two Quality reviews after screening to avoid any missing errors
Case TRIAGING by experienced professionals
Valid ICSRs processed under defined WORKFLOW STATES to teams
ICSRs further screened for Duplicacy check
Expedited ICSRs processed on priority basis for immediate reporting
Conduct two QUALITY Reviews before the case is locked for delievery.
Ensure timeliness, accuracy and completeness of the literature screening, review and assessment process

PDF FORMAT

  • Easy accessible format with identification of seriousness, expectedness, overdose, drug interaction and other case reports.
  • Accurate, Detail Oriented yet Concise, Well formatted reports generated by our system and reviewed by experts. Full citation details and links to the full-text where available, to support further research.
  • Delivery through data feed or email alerts.
  • Daily, weekly, or monthly alerts available.

E2B-Compatible XML files

  • Deliver E2b files within 24 hours for import into Global Safety Databases

We do provide trackers of each case screened, reviewed and processed which gives our Clients a full overview of their entire data for future references

 

 

SERVICES WITH ASSURED QUALITY

Our Quality assurance system guarantees that all the services are delievered with applied quality standards and documentation. Our processes are validated through ongoing monitoring and auditing.

Untitled Document

For Enquiry

Please do not send any Job Applications/Queries through this form

Contact Us

Address: HAROM Solutions
SCO 117-118, Level I
Sector 17B Madhya Marg
Chandigarh-160017
Phone No:- +91 172-4663037 , 9988756469
E-mail: info@haromsolutions.com
Contact us

Contact us for help, additional info or assistance and we'll be with you in no time!

Enter your name
Enter your email
Your message