Our Services

Clinytica offers a variety of clinical research services across all phases of drug development to simplify your journey to the market. By using our statistical programming excellence we maintain the high quality of scientific integrity, clinical trial results in adherence to quality standards and practices to reduce the cost of the companies. Our statistical programming team offers great flexibility according to the customer needs. Our team turns raw data into meaningful information to make clinical trial decisions, improving patient safety, drug efficacy, drug approval and drug launch process faster.

SDTM Creation

Having clean and organized data is the first step to the success of any clinical trial analysis. Thanks to the SDTM standards, which provide a perfect solution to this. Despite a detailed Implementation Guide, often the SDTM process gets complex while making choices. Our SDTM team is very familiar with this path, and will make your SDTM journey effortless.

ADaM

We consider ADaM datasets are one of the critical points in the entire statistical analysis process. These Analysis datasets are meant to simplify the derivations required to get data analysis ready and to have data traceability. Our analysis programming team will make sure to fully achieve these objectives while fulfilling SAP and protocol requirements.

CRF Annotation

SubmissionSubmission of Annotated Case Report Form(aCRF) is an essential part for the mandatory electronic submission process. Having Clean and Simple annotations on BLANK CRF is critical for statistical programmers and regulatory reviewers. We have tested methods in place to simplify the annotation process and make it accurate and cost effective. Not to mention, our clean aCRF ensures a smooth SDTM ride.

Mapping Specifications

We believed in Detailed SDTM Specifications to the extent of no ambiguity. Our expertized team will create custom specifications quickly and efficiently. Our centralized web based application provides easy access to draft, review and edit SDTM mapping specifications. It captures timestamps, versions, and users with minute details to help tracking all changes. With our versatile web based SDTM Specs, Import, export of various files types are at the fingertips.

SDTM Production

Our powerful macros integration with web based applications makes SDTM production much simpler and cost effective. We know precise planning of multiple interim SDTM are vital to ensure the success of subsequent events in the regulatory submissions chain.

SDTM Validation

Study tabulation datasets are fairly simple and straightforward, however, we are aware that many things could go wrong if abundant caution is not taken. This could impact the ADaM and TLF timelines, but we do know what it takes to prevent these setbacks. So we opted for 100% independent PROGRAMMING.

SDTM eSub package

In the highly regulated Pharma/Biotech industry, electronic submission is the future. We should see it as an opportunity to reduce reviewer time to a great extent, thereby a faster approval. Our expert team will focus on every minute details of the eSub package, such as .xpt files, define file, reviewer guide, aCRF, traceability, controlled terminology, and P21 compliance.

ADaM Mapping

Our Study statistician will fully review and approve the ADaM specs before finalizing the ADaM datasets, and our statistical team will make sure data is analysis ready as per the SAP and protocol. Our centralized web based application provides easy access to draft, review and edit ADaM mapping specifications. It captures timestamps, versions, and users with minute details to help tracking all changes. With our versatile web based ADaM Specs, import, export of various file types is at fingertips.

ADaM Datasets

To everyone's knowledge, analysis dataset programming is a complex activity, however, our ADaM expert team and statisticians will make sure everything goes correctly and as expected. 100% of independent programming of ADaM datasets is another layer of error proofing .

ADaM eSub package

We will ensure to provide all components of the esub package with maximum submission compliance. We believe a good eSub package should reduce reviewer time to a great extent, thereby a faster approval. Our expert team will focus on every minute details of the eSub package, such as .xpt files, define file, reviewer guide, programming files, dataset processing flow, traceability, controlled terminology, and P21 compliance.

Presentation Plan

Our clear and comprehensive mock shells will help to reduce turnover time to reports production. Study statisticians will review and approve the mock shells before the programming is finalized. Our web based mock shells are very flexible to draft, review and edit quickly along with history tacking. To further enhance the TLF programming macros are integrated to work with Web based presentation plans.

TLFs Production

Fully validated TLFs are provided based on the study priorities. Reports are strategically prioritized based on study requirements which will maximize programming efficiency and minimize the redundancy. Our powerful integration of web based presentation plan with programmes will help quickly produce standard and custom reports.

Senior Level Review

Our Senior Level Review Committee is comprised of Project Lead, Senior programmer and Senior statistician to make sure the reports are of the highest quality. Multiple eyes at different levels will ensure almost nothing can slip through.