CLINICAL STUDIES

YOUR SUPPORT FOR DEVELOPING INNOVATIVE MEDICINES AND GENERICS

PHA FARMED brings to the sponsor a flexible offering of functional service provision (FSP) when the sponsor decides to outsource certain clinical trials services.

The benefits of FSP collaborations for the sponsor are driven by enhanced cost savings, increased quality, improved timetables, stricter control and streamlined risk management.

Each clinical trial is a unique development project with its own unique challenges. Our team of experts have the knowledge and experience to tailor solutions for the sponsor’s unique needs and expectations, respecting Clinical Trials Regulation.

Clinical Trials Management

Clinical trials management collaborates across clinical trials processes and translational science, working closely with the sponsor’s team and each clinical site to deliver the real-time, biomarker and clinical endpoint data for critical decision-making.

We work effectively and diligently to manage specific aspects of the clinical trial to ensure on-time delivery of results, within budget and with the highest quality output.

  • Creation, collection and review of regulatory documentation
  • Negotiation of clinical trials contracts (budget, timelines)
  • Work directly with the competent health authorities
  • Frequent and timely reporting to the sponsor
  • Clinical trial and site management, consultation, support and supervision
  • Training the personnel on the Protocol, GCP and QMS
  • Consistent review of performance to ensure the quality standards are met

Medical Writing

PHA FARMED can support the sponsor by providing medical writing with the preparation and editing of different reports, including clinical reports, medical publications (abstracts, posters, etc.), protocols, journal articles or expert reports, applying different methods of reporting clinical trial results or procedures. Medical writing requests a strong scientific background of therapeutic areas, as well as detailed knowledge of EU Directives and national legislations, to be qualified to produce evidence-based documents.

  • Applications for national ethics committees
  • Clinical trials protocols / clinical investigation plans
  • Clinical trials reports (CSR)
  • Investigator brochures
  • Medical and scientific literature reviews
  • Trial Master File
  • Manuals, instructions for use, SmPCs

Safety Monitoring and reporting obligations

On behalf of the sponsors PHA FARMED can report information on the safety of clinical trial participants to the European Union (EU) Member States and European Economic Area (EEA) countries throughout the lifecycle of a clinical trial.

For clinical trials authorised under the Clinical Trials Directive, PHA FARMED can report the information below for assessment by the relevant EU and EEA authorities.

  • Reporting Suspected unexpected serious adverse reactions (SUSARs) to EudraVigilance. Reporting all other safety related information to the national competent authorities of the EU Member States / EEA countries and ethics committees via national processes and/or to national ethics committees.
  • Reporting unexpected events to Clinical Trials Information System (CTIS).
  • Urgent safety measures to be taken to protect clinical trial subjects due to an unexpected event that is likely to seriously affect the benefit-risk balance of the clinical trial.
  • Serious breaches against the clinical trial protocol or the Clinical Trials Regulation that are likely to significantly affect the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.
  • Annual safety reports. Yearly updates on the safety of each investigational medicinal product used in a clinical trial.”

Clinical Trial Site and Patient Recruitment

We alliance with the leading investigators and established clinical sites in the region. Clinical procedures, data management, monitoring and reporting are conducted according to the approved Clinical Trial Protocol and effective Quality Management System (QMS) in compliance with cGCP.

One of the big challenges and risks to completing the clinical trials studies and hitting timelines is recruiting the patients to match to the clinical trials’ criteria. Our developed network supports the quick identification of the patients and reach out to diverse patient groups.