Raptim Research

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RAPTIM
RESEARCH
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Some Of The New Technologies That We Are Working
With Are
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Clinical Trial Management System (CTMS)
Electronic Trial Master File (eTMF)

• Clinical Trial Management System (CTMS) is a set
  of tools for effectively planning, managing and
  tracking clinical study projects. It is a
  specialised, comprehensive project management
  application that takes the study from startup,
  through enrollment and monitoring till study
  close.
• CTMS is a suite of eClinical tools that, are most
  effective on following part
• Project Plan Track
• Monitoring Planning Management
• Contract Milestone Tracking (Sites Teams)
• Subject Visit Tracking
• Document Management

An eTMF is a Trial Master File in electronic
format. It is a way of electronic capturing,
managing, sharing and storing essential documents
and content related to clinical trials. Global,
real-time access, the ability to manage study
files and document workflows, collaborate, and
maintain all essential metadata and audit trails
are a few reasons why using an electronic format
is preferred by regulatory agencies and also by
organisations. Metadata used in this tool enables
a powerful search capability for quick retrieval
of documents for both inspectors and users. eTMF
has some additional guidelines to ensure
compliance by regulatory agencies. Both the USFDA
and the EMEA have released regulations, policies,
and guidelines to follow for validating the use
of this electronic format, the most widely
followed are 21 CFR Part 11.
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Remote Source Data Verification (rSDV)
CRED-Bio

• CRED Bio is a customised Complete Electronic
  Documentation System Designed for Data
  Integrity. This is for effective management of
  our Early Phase Studies. Our adaptation of new
  and improved technology has enabled us to achieve
• Advantages
• Complete tracking of the volunteer database and
  records
• Convenient sample management as data samples come
  in a neat format
• One central place to review study-related data
• No manual intervention needed, minimizes the
  chance of error
• Easier movement tracking
• All acceptance is handled by the system
• Eliminates the chances of backup skip or
  deviation

With the challenges of Covid-19 pandemic,
regulatory authorities are suggesting remote
approaches to conducting studies and more and
more trials are looking forward to utilising
remote technologies. By conducting SDV remotely,
we go one more step ahead with a risk-based
approach in clinical trials. With RBM techniques
it helps to improve the data integrity. With this
tool, it is possible for multiple sites source
data to be checked at a single centralization
location without physically visiting a particular
site.
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Phone
91-22-2778-1889 / 91-22-6831-6159
Website
https//www.raptimresearch.com
Address
INDIA (HEAD OFFICE) A-226 / A-242, TTC Industrial
Area, Mahape MIDC, Navi Mumbai 400 710
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THANK YOU
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