COMPUTERS IN CLINICAL DEVELOPMENT

Authors

DR. URMILA RAGHUVANSHI, Assistant Professor Shri G. S. Institute of Technology and Science, 23, Park Road, Indore, MP Pin - 452003; AISHWARYA JHALA, Assistant professor, Shri G S Institute of Technology and Science, 23 Park Road, Indore, Madhya Pradesh, Pin - 452003; DR. THENRAJA SHANKAR, Assistant Professor Arulmigu Kalasalingam College of Pharmacy, Krishnankoil Pin : 626126; DR. A JULLIYAN DILLEBAN, Assistant Professor, Dept of Pharmacy Practice, Arulmigu Kalasalingam College of Pharmacy, Virudhunagar, Tamilnadu, India, 626126; MR. GADGE SHUBHAM CHANDRAKANT, Assistant Professor, Department of Pharmacology Sanjivani College of Pharmaceutical Education & Research, Kopargaon, Pin - 423603

Synopsis

 

Computers have transformed clinical development by enhancing the efficiency, accuracy, and speed of data collection, management, and analysis throughout the drug development lifecycle. Their integration has revolutionized how clinical trials are designed, conducted, monitored, and evaluated.

???? Key Contributions:
  • Electronic Data Capture (EDC): Replaces paper-based systems with real-time, validated digital data entry, improving data quality and reducing transcription errors.
  • Clinical Trial Management Systems (CTMS): Streamline trial logistics, including site management, patient enrollment, drug accountability, and regulatory documentation.
  • Clinical Data Management Systems (CDMS): Enable secure storage, cleaning, and statistical analysis of trial data, with audit trails and discrepancy tracking for regulatory compliance.
  • Remote Monitoring & Wearables: Allow continuous patient data collection and real-time oversight, reducing site visits and enhancing patient safety.
  • Artificial Intelligence & Machine Learning: Detect patterns, predict outcomes, and support risk-based monitoring strategies.
  • Data Standards & Integration: Use of CDISC formats and interoperability protocols ensures seamless data exchange across platforms and stakeholders.
???? Impact & Future Outlook:

Computers have significantly reduced trial timelines, improved data integrity, and facilitated virtual trials. As technologies like AI, blockchain, and real-world data integration evolve, clinical development is poised to become more adaptive, decentralized, and patient-centric.

 

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Volume

COMPUTER AIDED DRUG DEVELOPMENT

Pages

190-220

Published

July 16, 2025
Copyright (c) 2025 Dr. I. Somasundaram, Mr. Praveen Sekar, Ms. Rohini Armo, Dr Bhupen Kumar Baruah (Volume editor); MS. SNNEHAA BHOSLE, NEHA ARORA, MONU KUMAR (MK GROVER), DR. T. DEBORAH PARIPURANAM, DR. AVINASH JORIYA, SANOBER PARVEEN, MR. YOGESH MATTA, MS. DHANASHRI DEVENDRA BORAWAKE, DR. URMILA RAGHUVANSHI, AISHWARYA JHALA, DR. THENRAJA SHANKAR, DR. A JULLIYAN DILLEBAN, MR. GADGE SHUBHAM CHANDRAKANT, DR. LAKSHMI, DR. S. REGHA, DR. VELENTI CHAUHAN, DR. MOIDUL ISLAM JUDDER, DR. MONIKA RAKSE, V. GEETHA, DR. MUKESH KUMAR MEENA, MS. PRAKRITI DIWAN UPADHYAY, DR. RITESH KUMAR, MS. SHRADDHA DINGARE, MS. KHANAPURE PRITI PARMESHWAR, DR. A JULLIYAN DILLEBAN, MS. PRAKRITI DIWAN UPADHYAY, DR. RITESH KUMAR, DR. RESHU TIWARI, Dr VINAY SAGAR VERMA, DR. FARAH DEEBA, MR. SHOUVIK MONDAL, MR. OMPRAKASH B, DR. KAVITHA S PATIL, MAYANDIGARI GURUVAREDDY, DR. JAYASANKAR NARAYANAN (Chapter Author)

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How to Cite

RAGHUVANSHI, D. U. ., AISHWARYA , A. J., SHANKAR, D. T. ., DILLEBAN, D. A. J. ., & CHANDRAKANT, M. G. S. . (2025). COMPUTERS IN CLINICAL DEVELOPMENT. In Dr. I. Somasundaram, M. B. K. . Baruah, M. P. . Sekar, & M. R. A. Armo (Eds.), COMPUTER AIDED DRUG DEVELOPMENT (pp. 190-220). Nexus Knowledge Publication (Imprint of AKT Multitask Consultancy). https://nknpub.com/1/catalog/book/8/chapter/24