Services

Striving To Be A Quality Focused Organisation
At Clinnex, we provide Biometrics services viz. Clinical Data Management, Statistical Analysis, Medical Writing & Clinical Data Standards and Consulting to pharmaceutical, bio-tech, medical device companies and Clinical Research Organisations (CROs). We strive to be a quality focused company, understanding the client requirements and the unique challenges in performing various types of clinical trials.

Apart from our extensive experience in robust Project Management which bonds all the Biometrics services, we also brings to the table experience in providing Biometrics support in various European languages through our tie up with our European counterpart. Our experience and understanding of Paper as well as Electronic Data Capture (EDC) processes and systems enable us to provide optimum solutions for each project.

Our experience covers all phases and design of clinical research, spanning across various therapeutic areas, and delivering high quality output. At the same time, our services are tailored to fit various clinical trial needs of our clients, starting from individual stand-alone services to execution of end to end services as per agreed standards.

Our Biometric Services
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Clinical Operations
Our Streamlined Clinical Operations strategies are derived from over 2 decades plus of experience.

Our Clinical Operations Services includes:

Targeted Feasibility Studies, Site Identification and Selection, IRB/EC Submissions, Site Contracts.

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Clinical Data Management
Our Clinical Data Management (CDM) team is involved in all aspects of clinical trial process, from CRF/eCRF development till DB closure.

Our CDM services include:

CRF Design, Database Design, Data Validation, Database Closure.

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Statistical Data Analysis
Clinnex has been involved in the analysis of data from all stages of clinical development with a variety of designs and statistical hypotheses.

Our statistical analysis services include:

Sample Size Calculation, Study Design (Protocol), Randomization, Statistical Analysis Plan.

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Pharmacovigilance Services
We cater to your changing pharmacovigilance / drug safety needs through our well defined processes originating across sources.

Our services includes:

Case Processing & Reporting, Serious Adverse Event Management, Signal Management, Risk Management.

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Clinical Data Standards
At Clinnex our team of expert programmers understands clinical trial data generation and all aspects of clinical research.

Our CDS service include:

Data Standards Library, Standards Mapping, Metadata Specifications, Programming Services.

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Medical Writing & Consulting
Our clinical study reports are produced by professionally trained medical writers and project statisticians.

Our services include:

Protocol, Clinical Study Report, ISE / ISS, Abstract.

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Remote Monitoring
Clinnex Remote Monitoring Services ensure effective trial monitoring, data integrity and cost efficiencies. We enable Remote Source Data Verification.

(rSDV) through the following methods:

Documents Sharing, Restricted access to Medical Records, Site Assessment, Centralised Monitoring.

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eTMF Services
We help make reporting of critical trial data easy, collaborative, real-time, secure and compliant, while reducing overhead cost, risk and timelines.

Our eTMF System/Services include but not limited to:

Ensuring Audit Ready, Efficient Indexing and Workflow, Ensuring Compliance, Ensuring Seamless Integration.

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