Our Clinical Research and Trials Services

Inno Infotech is proud to be part of the vast community of medical researchers and the beacon of hope to the millions of patients globally. Our commercial and vertical insight enables us to be at the forefront of providing clinical trial services to pharmaceutical companies with a special focus on Quality, Safety, and Security increasing the likelihood of achieving regulatory success.

Clinical Data Management

Quality of data is one of the most crucial aspects of the success of Clinical Trials. We have a team of experts to advise you on each step of Data Management from Collecting Raw Data to the Final Database Lock ensuring Quality, Safety, and Security all the while ensuring that compliances are followed. We think each trial is unique and therefore, requires a unique solution to achieve your drug development needs.
At Inno Infotech, we always update and implement industry best practice approaches to deliver solutions in this highly regulated market.

At INNO INFOTECH, we offer the following Data Management Services:

  • Design a Fully Customised Data Management System that suits your Clinical Trials Object.
  • Implementing a fully secure Data Management System.
  • CDISC CDASH compliant.
  • Expertise in handling Legacy Data
  • Data Cleaning and Extracting from Different Sources
  • Secure Data Transfer
  • Expertise in Clinical Database Platform RAVE, Oracle, IBM DB2, MS SQL
  • Data Integration with External Systems
  • Data Security, Integrity & Transparency,
  • Data Validation & Quality Checks
  • Data Query Management
  • Database Build
  • Database Lock

Statistical Analysis

Statistical Programmers and statisticians are the backbone of Clinical Trial Reporting. Our expertise in this can guide you through from the inception of the Clinical trial to the submission. Our team of experts makes sure that the trial is fully compliant with GCP practices and meets the regulatory requirements delivering the best healthcare solution to the patient and the sponsor.

Statistical Programmers and statisticians are the backbone of Clinical Trial Reporting. Our expertise in this can guide you through from the inception of the Clinical trial to the submission. Our team of experts makes sure that the trial is fully compliant with GCP practices and meets the regulatory requirements delivering the best healthcare solution to the patient and the sponsor.

At INNO INFOTECH, we offer the following Statistical Analysis Services:

  • Developing the Industry Standard SAP (Statistical Analysis Plan) Design a Fully Customised Data Management System that suits your Clinical Trials Object.
  • Handling Blinded and Unblinded Data
  • Randomization
  • Detailed and Most accurate TFLs for Reporting
  • Industry preferred programming environment SAS and R
  • Expertise in Mapping Legacy Datasets into the CDISC, SDTM
  • Talented programming team to produce the most accurate outputs and reports are produced
  • Quality Checks on Datasets, Tables, Listings, and Figures by double Programming
  • Detailed record of all the mismatches to keep transparency and the QC quality
  • High-level review by the Study Lead Statistician before releasing to the Client
  • Generating Define.xml and SDRG for the submission
  • Providing the up-to-date complete package including all the documents and the Reports for submission to Drug Approval Bodies such as FDSA, and EMEA.

Medical Writing

Medical Writing is an integral part of Clinical Trial submission. User friendly, well documented readable reports are important for the drug development program. Our partnership with highly trained and experienced professional medical writers with extensive knowledge of different therapeutic areas and an understanding of regulatory affairs, and compliances will help pharmaceutical companies to get their drug approved.

At INNO INFOTECH, we offer the following medical writing services:

  • Data Safety Update Reports
  • Data Safety Periodical Reports
  • Interim Analysis
  • Beneficial Drug Response
  • Post Marketing, Posters, Abstracts, Publication etc
  • ISS and ISE Reports for Drug Approval Submission with Drug Approval Authorities

TECHNOLOGY EXPERTISE