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)
Pharmacovigilance
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)
