• Technology/Digital Initiation/ Technology Adaptation

Advanced Technology

The Covid-19 pandemic has created new obstacles to overcome. At Raptim, we overcome these obstacles by adopting innovative techniques involving the use of advanced technology that enables us to manage clinical trials and studies more efficiently. We implement electronic tools that help us improve our outcomes in various domains. Regular training ensures that our team stays up-to-date with research, regulatory affairs and clinical trials in the industry. In addition to that, our team also undergoes training to work with various ERP software and management systems that are employed in the industry.

Some Of The New Technologies That We Are Working With Are

Clinical Trial Management System (CTMS)

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

Electronic Trial Master File (eTMF)

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.

Remote Source Data Verification (rSDV)

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 site’s source data to be checked at a single centralization location without physically visiting a particular site.

Spend less on CRA’s travel
CRAs are able to review the study documents and source data from anywhere
CRAs are able to review the same at any time

Thus, this has led to speeding up the process and reducing times to resolve queries as we no longer have to wait for physical source data verification.

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

The CRED-Bio Software is 21 CFR Part 11 compliant and fully validated.
This increases the efficiency of the studies with accuracy and quality.

Our adaptation of new and improved technology has enabled us to achieve

Data Integrity
Ease of Operation
Quick Search of Data
Availability of Full Audit Trail

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Dr. Rajen Shah
Founder & Director