Core services

Clinical Research

  • Product Development Strategy/Consultancy and Export Advise
  • Clinical Trial Design
  • Medical Oversight of Studies in Collaboration with Sites and Sponsor
  • Review of Patient Eligibility
  • Safety Evaluation for Dose Escalation
  • Medical Review of Study Safety and Effecacy Data
  • Medical Coding Review
  • SAE Reconciliation
  • Review of CRF, Logical checks, SAP and Study Reports

Regulatory Activities

  • EudraCT No Request
  • CTA/IND and Orphan Medicinal Product Designation (OMPD)
  • IMPD, Annual Reports
  • Competent Authority and Ethics Committee Filing and Negotiation

Study Management

  • Clinical and Operational Project Feasibility
  • Study Planning, Implementation and Close-out
  • Study Budget Recommendation and Monitoring
  • Clinical Study Material requirements and Accountability
  • Investigators and Site Identification and Recruitment
  • Feasibility Assessment and Qualification Visits
  • Monitors and Site Personnel Training
  • Monitoring and Monitoring Oversight
  • Study Tracking
  • Investigator Meeting Organization
  • Budget and Contract Negotiation and Contract Management
  • Import Licence for Study Drug and other Study Material
  • Export Licence for Laboratory Samples and other Study Material
  • Document Translation
  • Documentation Management, Filing and Archiving (Active and Passive)


Adverse Drug Reactions (ADRs)/Serious Adverse Events (SAEs) Management

  • Receipt and Registration
  • Assessment of Seriousness, Expectediness and Causality
  • Follow up Request
  • Triage into AERS® database
  • Data Entry
  • Coding with MedDRA® and WHO Drug Dictionary
  • Quality Control
  • Medical Review
  • Production of CIOMS I and XML file for Eudravigilance
  • Reporting to CA/EC
  • Notification to Investigators
  • Database Searching, Data Extraction, Queries on ADRs/AEs on Sponsor Request
  • Line Listings ans Summary Tabulation Preparation
  • Spontaneous Reporting of ICSRs in the EU via EV-Web (creation, validation and submission of safety reports to EVPM/EVCTM)
  • Creation, Validation and Submission of Product Reports to EVMPD via EV-Web
  • Acknowledgment Management

Clinical Data Management

  • Data Management Plan
  • Case Report Form, Design and Development (extensive library of Oncology specific modules available)
  • CRF Printing and Distribution
  • CRF Completion Guideline
  • Clinical Trial Database, Design and Development
  • Data Validation Specification, Programming and Testing
  • Single and Independent Double Data Entry
  • Data Discrepancy and Query Management and Resolution
  • Data Cleaning and Database Quality Control
  • Electronic Data Import/Interchange (EDI) Support
  • Coding Specialists to Assist Coding in Standard and Proprietary Coding Dictionaries such as MedDRA® and WHO DD
  • Functional Service Provider (FSP) for all Activities of “Full Service” Working Model Available
  • Paper and /or Electronic Data Collection Process
  • Fully Validated and Integrated Oracle Clinical®, TMS® and AERS® System
  • Fully Validated OpenClinica Enterprise EDC System

Biostatistics & Programming

  • Phase I-III Clinical Trial Design
  • Statistical Analysis Plan
  • Randomization Schedule
  • Definition of Oncology Standards, Derived Variables and Use of Applicable Coding Systems
  • Comprehensive Mock-ups Catalogue for Efficacy and Safety Reporting
  • Inferential Statistical Analyses, Including Survival Analysis, Logistic Analysis and General Linear Models
  • Exploratory Analysis, Including Biomarkers
  • FDA Item 11 Package
  • SAS Programming
  • Statistical Report

Medical and Scientific Writing

  • Clinical Development Plan
  • Investigator’s Brochure
  • Regulatory Documents: IMPD/CTA/IND/OMPD
  • Study Protocol (classical + innovative designs)/Amendments
  • Informed Consent Documents
  • PSURs
  • Clinical Study Reports
  • Literature Reviews
  • Abstracts/Posters/Oral Presentations
  • Journal Articles

Quality Assurance Services

  • Quality Management (SOP, Quality Manual Writing)
  • Auditing (Clinical Trial site and System Audit)
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