Our Services

Feasibility Assessments

Context

Throughout our professional experience we have built up an extensive database of key opinion leaders, qualified researchers, investigators and professional sites across a wide range of therapeutic areas. Furthermore, we continually identify new potential researchers through advertising campaigns, referrals and networking.

Our database of investigators is an important resource allowing us to conduct a realistic feasibility assessment at very short notice leading to the selection of the best investigational sites, the correct number of sites and accurate patient recruitment rates, never losing sight of the specifics of your individual project. We also survey different patient advocacy groups which enables us to target the appropriate investigators and provide the best feedback.

Our Services

- Early Stage Clinical Trials
- Phase II and III Clinical Trials
- Late Phase Clinical Trials
- Post Marketing Safety Studies
- Product Value and Effectiveness in Real-world
- Public Health and Social Science Research

Our honesty and professionalism in this area mean you will be in a position to make the correct decisions on how to conduct your projects based on current factual information.

Click here to find out how we can help

Data Management

Context

Pharmalys has forged partnerships with well established biometrics companies in order to provide a full range of state of the art services.

Based on your needs, we can deliver a comprehensive, customised and regulatory compliant solution to ensure a successful completion of your project.

Our Capabilities

Early Stage Clinical Trials / Phase II and III Clinical Trials
Late Phase Clinical Trials / Post Marketing Safety Studies
Product Value and Effectiveness in Real-world
Public Health and Social Science Research

Our Services

- Advice on paper-based or electronic data capture
- CRF design and review
- Data management plan
- Database design and validation
- Data entry
- Coding (adverse events, medical history, medications)
- Data clarification
- Sample size and power calculations
- Randomisation
- Statistical reporting and analysis plan
- Statistical analysis

Click here to find out how we can help

Quality Assurance

Context

We perform audits at all stages and on all processes used in the management of clinical trials and health related studies to assess adherence and compliance with SOPs, GCP, regulatory requirements, study protocols, client instructions and contractual obligations.

Our Capabilities

Early Stage Clinical Trials
Phase II and III Clinical Trials
Late Phase Clinical Trials
Post Marketing Safety Studies
Product Value and Effectiveness in Real-world
Public Health and Social Science Research
Scientic and Clinical product Support
Pharmacovigilance

Our Services

- Investigational site facilities
- Study data
- Trial master files and investigator site files
- Monitoring compliance
- Clinical trial documents including clinical trial reports

We can also provide the following ad-hoc services:
Review of current structure and policies, processes and documentation

Identification of corrective and preventive actions for process improvement

Implementation of a comprehensive and efficient system enabling a consistent quality structure

Writing, reviewing or updating SOPs

Click here to find out how we can help

Clinical Operations

Our Services