Our Services
Clinical Monitoring
Our Clinical Research Associates (CRAs) are one of the strongest links in the chain of a clinical study and act as the main line of communication between investigators and our clients. While always ensuring subjects’ wellbeing and rights and data reliability, they promote and uphold the image and values of our clients’ company at all times.
Their professionalism and enthusiasm is second to none in the market. We offer our CRAs a comprehensive internal and external training program featuring Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and regulatory requirements. In addition, they receive project specific training before the start of any projects. All monitoring activities are conducted according to the international standards of ICH/GCP.
With the support of their Project Manager and Line Manager, our CRAs are accountable for:
- Investigational site identification and qualification
- Collection, review and tracking of essential documents
- Site initiation, ongoing monitoring and closure of investigational sites
- Reporting and tracking of monitoring activities
- In-house site management
Project Management
Our highly-skilled Project Managers are driven by the passion, dedication and expertise required for this fundamental aspect of your projects. Your dedicated Project Manager is your primary point of contact throughout the entire project. He/she works hand in hand with your project team and listens closely to you to develop an individualised approach to your specific project. With the support of a Director of Operations and Line Manager, your Project Manager is accountable for:
- Upfront planning, preparation of a road map
- Project team set up
- Global coordination of teams
- Ongoing anticipation of risks
- Proactive preparation of back-up scenarios and, implementation of corrective actions as and when necessary
- Ongoing tracking of key milestones and budgets
- Reporting to all stakeholders
Medical Affairs and Safety
Our partners come from a professional life sciences background with substantial regulatory and interdisciplinary experience to support your projects.
Our Services Include preparing:
- Protocols
- Investigator Brochures
- Paediatric Investigational Plans
- Patient Information Sheets and Informed Consent Forms
- Presentations for scientific advice meetings with the local and international regulatory bodies
- Publications, abstracts and posters
- Trial reports
Regulatory Affairs
The preparation of clinical trial applications to and liaison with Ethics Committees (EC), Competent Authorities (CA) and Ministries of Health (MoH) are specialised regulatory tasks. For large multi-centre studies efficient completion of this step can make all the difference between meeting the projected timelines and being left behind.
At Pharmalys we have experienced staff dedicated to managing the ethics and regulatory approval processes. Our in-depth knowledge of local and international regulatory requirements guarantees that regulatory approval processes are expertly managed by associates who have many years of experience in this area.
Our Services include:
- Preparation of the submission dossier for ECs and CAs/MoHs
- Attendance at EC meetings together with the sponsor and/or Chief Investigator
- Liaison with CAs/MoHs
- Support given to investigational sites/research institutions for their local submissions
- Communication of approvals in a timely manner
- Periodic reporting required by ECs and CAs/MoHs on study status and safety information
- Pharmalys also provides regulatory support for applications for market authorisation of new drugs or new indications
Feasibility Assessments
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.
Site Identification
We are fully aware that the ultimate success of a study is linked to the selection of appropriate, qualified and productive sites, which is why we put a particular emphasis on site identification.
We can take full responsibility for the initial selection of sites or combine your own database with our lists.
Our process includes a detailed evaluation of the following aspects:
- Past history of clinical study/research involvement
- Investigator competencies and experience in clinical trials and health research studies
- Availability of co-investigators and research team
- Team workload
- Ongoing competing projects
- Training of site staff in ICH-GCP, other regulatory requirements and local procedures
- Site facilities and equipment
- Recruitment potential
Wherever possible we also maintain a list of backup sites in an operational state on stand-by that can be quickly initiated if additional sites or site replacement are required.
Quality Assurance
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 services include the following types of audit:
- 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
Patient Recruitment and Retention
We can help design a strategic programme to address recruitment barriers and challenges specific to a given study protocol and/or identify the leverage opportunities in order to accelerate patient recruitment.
Following a detailed review of the study protocol and assessment of the patient population, we generate a list of potential tactics along with the areas in which they can be implemented. Each action and the assessment of its pros and cons are discussed within the project team leading to a consolidated action plan.
The following actions can be very useful and cost-effective: site tools for subject enrolment, advertisement campaign to increase awareness of the study being carried out (web, radio, and posters), establishing local professional networks for patient referral and mailing to local doctors.
Data Management and Biostatistics
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 services include:
- Advice on decisions regarding 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
Scientific Translation
Our translators are native speakers and deliver high quality and accurate document translation that forbids compromising of your original message.
Our services include translation of:
- Medical/Scientific documents
- Clinical Protocol Synopsis
- Medical/Scientific Articles
- Contracts and agreements
Strategic Consulting
We can support you with the provision of strategic or operational consultancy services thanks to our broad knowledge of the industry, extensive hands-on experience, objective perspective and tailor-made problem solving methods.
We will provide you with clear, straightforward, pragmatic advice enabling you to achieve your projects’ ultimate goal using the most efficient route.
Our services include scientific, regulatory, operational and business consulting for:
- Product development
- Programme/study planning and conduct
- Process design and improvement
- Resource planning and management
