EXCLUSIVE ARTICLE
Essentially, the most critical component of clinical trials are biostatistics and statistical programming. Yet, with broad knowledge base the success of the clinical trial process from the initial set-up to the final analysis. Experts plan the analysis during the study before one commences the study until they provide reports and statistical summaries. Additionally, clinical experts need to ensure the efficacy and conduct safety analyses promptly and accurately during the course of the study as it progresses.
We discuss leveraging your study and clinical trials with biostatistics and statistical programming.
Having a team of top-notch experienced professionals
Amongst the most critical factors that you need to imbibe in your clinical trials is the ability to have a team of high-end research professionals who have the highest qualifications in the field. Major technological consultants have the ability to deliver significant technological results in the CDISC standards which are required for consistent reporting towards the necessary regulatory authorities. One should be on the lookout for global standard operating procedures that have a detailed and extensive knowledge of the necessary worldwide regulatory requirements.
What you will need are the following:
- Statistical Analysis Plans
- Generate Tables
- Listings and Figures
- Access to reports
- Statistical summaries
- Safety analyses and efficacy in the reports
What are the essential ways to improve biostatistics and statistical programming?
Technological majors like HCL Tech ensure that SOPs are consistent and integrate study results. With a multi-stage procedural and a highly scientific quality control process, there are periodic reviews conducted on programming standards. Other factors that need to be assessed are the amount of flexibility involved in accommodating changes to various project specifications. This should be accompanied by an audit trail and a thorough maintenance of quality of study data and adherence to expected study timelines. It’s important a statistical experience to various design studies in order to speed up submissions. Take into account the following factors while looking for optimal services:
- Protocol development, that includes power and sample size calculations
- Quick randomization schedules
- SAP
- SAS Statistical and Clinical Programming
- CDISC Study Data Tabulation Model or SDTM that includes Mapping & Conversion, generation of ADaM or analysis of Data models
- A thorough Analysis Dataset Programming and documentation
- Prompt Decision making enhanced with Interim analysis
- Thorough list of Tables, Listings and Figures Validation and Quality Control
- Integrated Summary of Safety (ISS) and Efficacy (ISE) summaries
- Immediate and Ad hoc Statistical Support
- Conducting a Meta-Analysis – having a set of statisticians detect the potentials for bias during a regular Meta-Analysis as well as assessing the statistical methods used.
- Ensuring you have a statistical representative at FDA regulatory pre and post-submission meetings
- Access to a correct interpretation and reporting of data required for the clinical trial reports and publication.
To know more about the topic please visit HCL Technologies.
Source : HCL Technologies
