Your Clinical Trial deserves superior Medical Expertise.

Medical Experts for the intersection of Clinical Research and Drug Safety.

The “Vigilance” in your Pharmacovigilance.

Our Services

We offer a variety of expert medical services to help enable a successful clinical trial.

Medical Oversight of Research Projects

Medical Management

Oversight Medical, safety and scientific aspects of Phase I – IV Projects
Development of Study Concepts and Design of clinical trials
Medical expertise for DSMB, IRC and Steering Committee.

Medical Monitoring

24/7 Medical Monitoring
Medical and scientific support to study sites and project teams.
Response to queries and Interaction with Investigators, IRBs, ECs and Authorities.
Regular review of study data

Medical Input and Documents Review

CTP, ICF, CRF, CSR and IBD
Translated Study document in 4 different languages (English, French, Dutch and Arabic).
Scientific Publications and Marketing and Promotional Materials.

Medical Review of Clinical and Safety Data

AEs, Lab results and Concomitant Medications
Medical Review of Data Listings, Validation and Coding
Review of TFLs
Medical Review of SAEs
Medical Review of Event Narratives

Drug Safety and Pharmacovigilance

Safety review and reporting: IND safety reports, ASR, PSUR, DSUR
Monitoring Pharmacovigilance system compliance including Pharmacovigilance procedures documentations and the Pharmacovigilance Systems Master File (PSMF)
Eudravigilance / adverse events electronic reporting.
Pharmacovigilance Auditing co-licenced partners and distributors who signed pharmacovigilance (SDEA) safety agreements with the MAH.
Pharmacovigilance Risk Management Plan (RMP) Implementation (pre-authorisation / post-authorisation phase)
Literatures reviewing / ICSRs assessment & reporting
Clinical & Non-clinical expert reporting
Pharmacovigilance (SDEA) Agreements
Registration of the MAH Pharmaceutical products in XEVMPD

Training & Development

Medical Training for non-medically qualified

Medical terminology
Medical Investigations in Clinical Trials: ECG, Clinical Laboratory Investigations and Clinical Imaging.

Therapeutic Areas Training

We developed a wide range of TAs training to strengthen the medical knowledge of non-medically qualified staff. Each TA training includes a variety of modules to provide the basic knowledge in addition to in-depth reviews of different disease indications within the TA.

Examples of TA Trainings

Oncology
Virology
Vaccines
Solid Organ Transplantation
Stem Cell Transplantation
Abdominal and Bariatric Surgery
Oncology Surgery

Clinical Research and Drug Development Trainings

Introduction to Clinical Research
ICH-GCP
EU Clinical Trials Directive
Phases of Drug development
Study Design
Early Access Programs

Clinical Operations Trainings

CRA Essentials
A Training course includes 15 training modules that provide CRAs with the essential knowledge in a wide range of Operational, Ethical and Regulatory aspects.
List of the training modules within the "CRA Essentials" course
Cold Chain Management for vaccines and biologics
Protection of Subjects Confidentiality in Clinical Trials

Pharmacovigilance Training

Pharmacovigilance Modules and MAHs obligations.
Monitoring Pharmacovigilance system compliance (Be ready for Pharmacovigilance inspection by regulatory authorities)
Eudravigilance / EVEWEB and ICSRs electronic reporting
Mandatory pharmacovigilance SOPs
Safety Reporting (PSUR / DSUR) and the mandatory new requirements
Literatures reviewing / ICSRs assessment
Risk management plan (mandatory requirements in Pre- / Post-authorisation phases)
Pharmacovigilance (SDEA) agreements (distributors / Co-license partners)
Auditing distributors & Co-license partners for Pharmacovigilance (SDEA) agreements compliance

Clinical Project-specific Training

Specifically-designed training to meet the requirement of a specific project including the protocol, study drugs, TA and safety procedures

Our Services

Useful Links