Please check Cdisc sdtm Internship details below.
Click Here to View Cdisc sdtm Internship Program Structure
Traversing Diverse Cdisc sdtm Research Horizons: Specialized Research Methodologies and Varied Topics Unveiled
Research Methodologies focussed for Internship students under Cdisc sdtm:
Various approaches where Internship candidates will be exposed under CDISC, SDTM, and ADaM standards:
CDISC Project Approaches
1.
Standardizing Data Collection
Implementing CDISC standards for consistent and standardized data collection across clinical trials.
2.
Training and Education
Providing training programs to educate staff and stakeholders about CDISC standards and their implementation.
3.
Compliance Assessments
Regularly assessing compliance with CDISC standards to ensure data accuracy and consistency.
4.
Integration with EDC Systems
Integrating CDISC standards into Electronic Data Capture (EDC) systems for seamless data entry and validation.
5.
Data Mapping and Transformation
Mapping existing data to CDISC standards and developing transformation processes for smooth transition.
6.
Metadata Management
Managing metadata to ensure accurate representation of clinical trial data according to CDISC standards.
7.
Version Control
Implementing version control systems to track changes and updates in CDISC standards and datasets.
8.
Cross-Functional Collaboration
Facilitating collaboration between different departments to ensure CDISC standards are implemented consistently.
9.
Quality Control Checks
Conducting regular quality control checks to identify and rectify discrepancies in CDISC compliant datasets.
10.
Data Migration Strategies
Developing strategies for migrating legacy data into CDISC compliant formats.
11.
Customizing CDISC Standards
Customizing CDISC standards to meet specific trial requirements while maintaining compliance.
12.
Regulatory Compliance
Ensuring that CDISC standards implemented align with regulatory requirements in different regions.
13.
External Vendor Collaboration
Collaborating with external vendors to align their data formats with CDISC standards for seamless integration.
14.
Data Review and Validation
Establishing processes for thorough review and validation of CDISC compliant datasets before submission.
15.
Implementing CDASH Standards
Utilizing Clinical Data Acquisition Standards Harmonization (CDASH) for consistent data collection.
16.
Post-Trial Archiving
Developing protocols for archiving CDISC compliant datasets after the completion of clinical trials.
17.
Continuous Improvement
Continuously evaluating and improving CDISC implementation processes based on feedback and lessons learned.
18.
Data Privacy and Security
Implementing robust data privacy and security measures in line with CDISC standards.
19.
Risk-Based Monitoring
Applying risk-based monitoring techniques to identify potential issues in CDISC compliant datasets early on.
20.
Documentation and Auditing
Maintaining detailed documentation and conducting regular internal and external audits to ensure CDISC compliance.
SDTM and ADaM Project Approaches:
1.
SDTM Dataset Creation
Creating SDTM datasets based on collected clinical trial data for regulatory submission.
2.
ADaM Dataset Development
Developing ADaM datasets for statistical analysis and reporting purposes.
3.
Metadata Standardization
Standardizing metadata across SDTM and ADaM datasets for consistency.
4.
SDTM Mapping and Validation
Mapping clinical trial data to SDTM domains and performing validation checks.
5.
ADaM Mapping and Validation
Mapping SDTM datasets to ADaM datasets and performing validation checks.
6.
Integrated SDTM/ADaM Datasets
Creating integrated datasets linking SDTM and ADaM for comprehensive analysis.
7.
Dataset Specifications
Developing detailed specifications for SDTM and ADaM datasets.
8.
Statistical Programming
Writing and validating programs for analysis using ADaM datasets.
9.
Data Traceability
Ensuring traceability of data elements from source to SDTM to ADaM datasets.
10.
Define.XML Creation
Generating Define.XML files describing SDTM and ADaM datasets for regulatory submissions.
11.
ADaM Interim Analysis Datasets
Creating interim analysis datasets based on ADaM standards for ongoing trial assessment.
12.
Data Standards Governance
Establishing governance frameworks for maintaining SDTM and ADaM standards within the organization.
13.
Data Integration
Integrating SDTM and ADaM datasets with other databases and systems for comprehensive analysis.
14.
CDISC Compliance Checks
Conducting regular checks to ensure SDTM and ADaM datasets comply with CDISC standards.
15.
Protocol Deviations Handling
Implementing protocols for handling and documenting protocol deviations in SDTM and ADaM datasets.
16.
Database Lock Procedures
Developing procedures for database lock and finalization of SDTM and ADaM datasets.
17.
Data Submission Preparation
Preparing SDTM and ADaM datasets for regulatory submission in the required format.
18.
Statistical Analysis Planning
Planning statistical analyses based on available ADaM datasets.
19.
Data Reconciliation
Reconciling data between SDTM, ADaM, and other clinical trial databases to ensure consistency.
20.
Continuous Process Optimization
Continuously optimizing SDTM and ADaM processes based on project outcomes and industry best practices.
Testimonials
VB. Bhavana View on Google
I have completed my 6 month dissertation in NTHRYS biotech labs. The lab is adequately equipped with wonderful, attentive and receptive staff. It is a boon to the students venturing into research as well as to students who would like to garner lab exposure. I had a pleasant experience at NTHRYS thanks to Balaji S. Rao Sir for his constant support, mettle and knowledge. I would also like to give special regards to Zarin Mam for teaching me the concepts of bioinformatics with great ease and for helping me in every step of the way. I extend my gratitude to Vijaya Mam, and Sindhu Mam for helping me carry out the project smoothly.
Durba C Bhattacharjee View on Google
I have just completed hands on lab trainings at NTHRYS in biotechnology which includes microbiology, molecular and immunology and had gained really very good experience and confidence having good infra structures with the guidance of Sandhya Maam and Balaji Sir.
Recommending to any fresher of biotechnology or microbiology field who wants to be expert before joining to
related industry.
Razia View on Google
Best place to aquire and practice knowledge.you can start from zero but at the end of the internship you can actually get a job that is the kind of experience you get here.The support and encouragement from the faculty side is just unexplainable because they make you feel like family and teach you every bit of the experiment.I strongly recommend NTHRYS Biotech lab to all the students who want to excel in their career.
Srilatha View on Google
Nice place for hands on training
Nandupandu View on Google
Very good place for students to learn all the techniques
Sadnaax View on Google
I apprenticed in molecular biology and animal tissue culture, helped me a lot for my job applications. Sandhya and Balaji sir were very supportive, very helpful and guided me through every step meticulously. Helped me learn from the basics and helped a lot practically. The environment of the lab is very hygienic and friendly. I had a very good experience learning the modules. Would recommend
Shivika Sharma View on Google
I did an internship in NTHRYS under Balaji sir and Sandhya maam. It was a magnificent experience. As I got hands-on experience on practicals and I was also provided with protocols and I learned new techniques too.This intership will help me forge ahead in life. The staff is very supportive and humble with everyone. Both sir and maam helped me with my each and every doubts without hesitation.
Digvijay Singh Guleria View on Google
I went for 2 months for different training programs at NTHRYS Biotech, had a fun learning experience. Everything was hands-on training and well organised protocols. Thank you Balaji sir and Sandhya mam for this life time experience.
Anushka Saxena View on Google
I’m a biotechnology student from Dy patil University mumbai and I recently completed my 6 months dissertation project at Nthrys Biotech Labs in Hyderabad. I had a great experience and I would highly recommend this lab to other students as well .
The first thing that I appreciated about Nthrys Biotech Labs was the friendly and supportive environment. Balaji sir and the staff Ragini and Sandhya ma’am were always willing to help me and they were always patient with my questions.
I also felt like I was part of a team and that I was making a real contribution to the companys research.
I learned a lot during my dissertation at Nthrys Biotech Labs not only academically but also personally . I had the opportunity to work on a variety of projects, which gave me a broad exposure to the field of biotechnology. I also learned a lot about the research process and how to conduct experiments.
In addition to the technical skills that I learned, I also developed my soft skills during my internship. I learned how to communicate effectively, how to work independently, and how to work as part of a team.
Overall, I had a great experience at Nthrys Biotech Labs and I would highly recommend this company to other students.
Once again I would like to render a big thank you to Balaji Sir and Vijayalakshmi ma’am for imbibing with all the knowledge along with helping me publish my research paper as well and its all because of them I scored unbelievably well in my final semester.
Nithin Pariki View on Google
Lab equipment and protocols are good, it gives good hands on experience for freshers.
