Biostatistics
Biostatistics is an integral part of the investigational drug development procedure. It assists in asserting the effectiveness and efficiency of clinical trials. KnowTechInfo is home to a team of highly qualified and experienced biostatisticians who strive to offer top-notch statistical services consistently across multiple studies that we have supported throughout.
Our team members come with hands-on experience in studies of both pre-development and post-development life cycles across all the phases. These phases are namely, Phase I, Phase II, Phase III, epidemiology studies, post-marketing studies, proof of concept, and market access studies. Every study would be meticulously spearheaded by Biostatisticians with vast expertise ensuring market-best results.
Our team provides tailor-made biostatistical services along with the following:
Protocol Development
- Study Design Selection To Efficiently Reach The Goals Of The Protocol
- Selecting Suitable Statistical Analysis Methods
- Writing The Protocol While Collaborating With the Clinical Team
- Calculation Of Sample Size, Inclusion Of Simulations As And When Necessary For The Study Design
Randomization Schedules
- Kit Allocations And Material Lists
- Complex Stratified Allocations
- Dynamic And Traditional Allocation Schemas
Statistical Analysis Plans
- Comprehensive SAP Which Are Compliant With ICH E9
- Listing, Figure Shell And Table Delivered With Statistical Analysis Plan
Statistical Report Writing
Exploratory Analysis And Data Mining
Preparing CRTs (Case Report Tribulations)
Statistical analysis and support for interim analyses and Data Monitoring Committee (DMC)
- Both Unblinded And Blinded Support With Firewalls For Preserving The Trial Integrity
- Complete DMC (Data Monitoring Committee) Support For Charter Preparation, Statistician Representation, DMC Analyses
Integrated Summary Of Efficacy (ISE) And Integrated Summary Of Safety (ISS)
Pharmacoepidemiology Analysis And Design
There’s more to our Biostatistical services in addition to the one mentioned above. Our team of Biostatisticians are skilled in the following fields as well:
