Clinical Data Management

Managing Clinical Data in the existing complex regulatory scenario is the most challenging task. With R&D costs spiraling upwards, patents expiring on many molecules and stringent FDA requirements for new drug approval, it is imperative that there is need to reduce time-to-market and minimize costs.

At KV Bio Services, we understand clinical data management challenges. We offer end-to-end clinical data management solutions integrating technology and clinical data expertise, supported by a robust quality management framework to deliver high quality data.

KV Bio Services offers end-to-end clinical data management services which include:

  • CDM Project Management
  • Case Report Forms (CRFs) Design
  • CRF Annotation
  • CRF Completion Guidelines
  • Clinical Database Design and Deployment
  • Edit Check Programming and Testing User Acceptance Testing
  • Data Management Plan
  • CRF Scanning and indexing (paper studies)
  • Double Data Entry and Verification (paper studies)
  • Query Management and Resolution
  • Clinical Data Validation & Quality Assurance
  • Medical Coding (MedDRA and WHO-Drug)
  • Handling of External Data
  • Generation of System Reports and Data Listings
  • Serious Adverse Events (SAE) Reconciliation
  • Interim and Final Data Base Locks
  • Filing and Archiving

Biostatistics & Programming


  • Clinical Trial Design
  • Sample Size Calculations
  • Statistical Input to Protocols
  • Statistical Analysis Planning and Interpretation
  • Statistical Reports

Statistical Programming

  • SAS Datasets Creation as per CDISC
  • Program Validation
  • Integration of Databases across Protocols
  • Integrated Summaries of Safety and Efficacy

CDISC Implementation

CDISC (Clinical Data Interchange Standard Consortium) is the most widely accepted standards for exchange of clinical trial data. Under the ICH's electronic Common Technical Document (eCTD) guidance, CDISC Study Data Tabulation Model (SDTM) is the preferred standard for content format and structure of clinical data for all clinical studies. Based on proposed federal regulations, to comply with data standards guidance Pharmaceutical industry is rapidly adapting to CDISC standards.

We specialize in the following:

  • Conversion of Legacy data to CDISC
  • Creation of SDTM Annotated CRF
  • Implementation of CDASH standards
  • Implementation of SDTM and ADaM standards
  • Validation of SDTM datasets
  • Creation and validation of Define.xml
  • CDISC guidance and training
  • eCTD submissions

Medical writing

This service entails the generation of well-structured individual reports to extensive medical writing programs, including:

  • Clinical Study Protocols
  • Clinical Study Reports (ICH-E3)
  • IND Annual Reports (21 CFR 312.33)
  • Clinical Summaries/Product Feasibility Reports for Medical Devices
  • SAE Narratives
  • Manuscripts and Publications
  • Patient Diary Cards (PDC), Informed Consent Form (ICF), Subject Information Sheet (SIS), Case
  • Report Forms (CRFs)

Our medical writers have a strong academic; pharmaceutical and biotechnology industry background and can help you prepare clear, concise, and high quality;

  • Investigator Brochure
  • Protocol
  • Case Report Form
  • Patient information leaflets
  • Informed Consent Form
  • Safety data reports
  • Medical translation services
  • Study related Forms and Logs

Pharmacovigilance & Drug Safety

This service area entails the processing of individual case safety reports (ICSRs) originating from various sources:

  • Post-marketing non-solicited/Spontaneous reports
  • Clinical reports
  • Special reports (Medico-legal, Literature & E2B)
  • Related services

Licensed from Oracle, KV Bio Services has implemented the Argus Safety database and is qualified to use this industry-accepted and proven adverse event management system. This platform enables us to deliver consistent regulatory compliance. Our safety system services cover all aspects of implementation -Technical, functional, regulatory, validation, training and on-going support. Our scientists and in-house trainers help us stay abreast with Oracle Argus safety and its capabilities, in order to maintain quality and compliance.

A proven and audited track record of trust earned from major global pharmaceuticals companies.

A strong set of values and passionate regard for ethics lived up to by the entire staff every day. 3. A team rich in experience, qualification, maturity and stability, led by Professionals with 12 years of experience in Drug Safety and International Quality Management

Senior team with vast experience and with thousands of single cases processed individually

Exposure to a very wide range of therapeutic areas, products and studies

Extremely low staff turnover, resulting in industry-leading stability

Focused on quality, our team has established an excellent, enviably high and measurable track record in this domain.

KV Bio Services robust, high-class and refined technical infrastructure utilizes the Microsoft Dynamics NAV information system, operates on virtually zero downtime, and provides optimal data security and rapid turnaround times.

World-class training:

KV Bio Services certified team of trainers ensures a focus on constant training and retraining of its scientific staff in a seamless manner.

Regulatory & Compliance

21 CFR Part 11 Compliance

  • Computer access controls: Multi-layered Password, session timeouts
  • Audit trails and other login securities
  • Date/Time Stamps
  • Systems Used for direct data entry and EDC
  • System dependability tested continuously
  • Copies of records and record inspection maintained securely
  • Certification of electronic signatures

Regulatory Affairs

  • Pre-IND meetings, IND preparation
  • End of phase 2 FDA meetings
  • Investigator Drug Brochures
  • FDA interaction
  • EU Commission, European countries
  • MHLW, Japan
  • DCGI, India
  • Support IND & NDA submission

Clinical Monitoring

KV Bio Services provides comprehensive site monitoring and management, including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites. Our Clinical Research Associates (CRAs) act as the liaison between the sites and the study team. Our CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with ICH GCP compliance and data integrity during each site visit, consistently retrieving high quality, on-time data. Our Clinical monitoring team ensures the adherence with standard operating procedures (SOPs) and strives to promote positive personal relationships with a high level of trust and confidence with all our customers.

Our CRAs are both office and regionally based and are experienced in numerous therapeutic areas across drug, biologic and device trials. All of our CRAs have state-of-the-art communications tools in place to provide timely and responsive communications, real-time data accessibility and centralized tracking and management of procedures.

Our Clinical Monitoring services include:

  • Site Identification
  • Site Qualification and Initiation
  • Subject Accrual/Retention Strategy Enhancement
  • Regulatory Document Preparation and Collection
  • Budget and Contract Negotiation
  • Investigator Meeting Planning and Presentation
  • Site Personnel Training
  • Interim Site Monitoring
  • Clinical Study Material Accountability
  • Site Termination

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