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Pharma Clinical

Pharma Clinical group is a well-established Clinical Research Organization since 1988. In 2007 the company extended its capabilities to provide CRO services in Europe, North America and Israel.

Providing drug development and clinical management services

Pharma Clinical offer clinical development services for international pharmaceutical, bio-technology and medical device companies including phase I-IV clinical studies in a range of therapeutic areas, such as:

  • Cardiology
  • Oncology
  • Infectious diseases
  • Metabolic
  • Hematology
  • CNS
  • Respiratory
main areas

Wide range of product development services for biopharmaceutical companies

Pharma Clinical has set up a network of local people who have the experience and local knowledge of study conduct. In addition, Pharma Clinical has well established relationships with experienced key opinion leaders (KOLs) and investigators that support the company in feasibility processes and site identification in a variety of therapeutic areas.

Pharma Clinical Group has been involved in more than 550 clinical studies for which more than 40,000 subjects were recruited in more than 30 countries. Their network includes more than 200 experienced CRAs, Senior CRAs and project managers.

global coverage

Pharma Clinical has its own set of Standard Operation Procedures (SOPs) and can adapt itself to work according to the sponsors’ SOP, if this is required.

Pharma Clinical Group’s services cover the entire lifecycle of product development which can be adapted to local trials or large international clinical studies.

Our services include:

  • Study design, including statistical planning and protocol writing
  • Advice on patient recruitment strategies
  • Global project management
  • Regulatory submissions
  • Site selection & feasibility
  • Study set-up
  • Monitoring activities
  • Pharmacovigilance
  • DSMB (Data Safety Monitoring Board)
  • Data management
  • Statistics
  • QA
  • Medical report, narrative writing and publication support

Our expertise and capabilities establish an appropriate path for efficient clinical development

Pharma Clinical’s management team has over 15 years of experience in managing clinical studies in several operational models. Quality processes are embedded in Pharma Clinical Group’s delivery model. Their dedicated QA manager supports the project teams to ensure that established processes meet the needs of the project and that all the regulatory requirements are met. This quality approach is underpinned by an audit program.

Pharma Clinical has proven experience in supporting Pharma companies in meeting recruitment targets and project timelines, thus reducing the study cost and preventing possible delays.

turning vision into reality

Contact

Pharma Clinical AG
Baarerstrasse 135
CH-6300 Zug
Office: +41 41 720 20 25
Fax: +41 41 720 20 27
Mobile: +41 79 709 82 78

Cristina Varela
Management Associate
E-Mail: cristinav@pharmaclinicalag.com
Internet: http://pharmaclinicalag.com/

Advice on Patient Recruitment Strategies

Based on the specific indication and study population required and according to their net of local people and KOL, Pharma Clinical provide the sponsor with a recruitment strategic plan identifying the most potential countries and sites to be involved in a specific clinical study.

Global project Management

Pharma Clinical’s experienced project managers (PM) are the key person responsible for the management of a global clinical study. The PM is responsible for the setting up and the study as well as for sufficient drug supply, training and communication of site team members as well as ensuring that all study milestones will be met, as agreed with the sponsor.

Medical Writing

Their medical writing team has a tremendous amount of experience in the development clinical study protocols, clinical study reports (CSR), narrative writing and publication support. All regulatory documents are written in accordance with the ICH-GCP guidelines and the regulatory agenesis recommendations.

Monitoring Activities

Their dedicated qualified CRAs perform several visits at each site including: initiation visit, onsite monitoring visits and close out visits- end of study visit.

During initiation visit, the protocol and investigational product are presented including the relevant efficacy and safety data. The team responsibilities are defend by the site Principle investigator. Any additional training is being performed such as EDC. On-site monitoring visits are performed throughout the study to ensure all data collected is accurate, all data queries are…

Quality Processes

These are embedded in Pharma Clinical Group delivery model. Their dedicated QA manager supports the project teams to ensure that established processes meet the needs of the project and that all the regulatory requirements are met. This quality approach is underpinned by an audit program.

Regulatory Submissions

The trialforce platform provides a fully integrated web-based regulatory submissions solution specifically designed for regulated Life Science eDMS and international eCTD submissions.

Key advantages:Provides all standard international templates for regulatory submissionsProduces output in required format including eCTD and NeESValidates outputLocking mechanism for SubmissionsProvides 21 CRF Part 11 compliant audit-trail 

Site Selection & Feasibility

Based on the specific indication and study population required they perform a detailed feasibility process, which accordingly provide their recommendations regarding the most suitable and promising sites.

Study Set-Up

The study set up period is one of the most important phases. During this period the study strategy and plan should be defined and carried out. This includes: monitoring plan, allocation of providers, (such as central laboratory), sites identifications, sites agreement negotiation, CRF design, protocol finalization, regulatory submission process and others. A high-quality planning process will avoid many issues during the active phase of the study.

Quick Contact Pharma Clinical
Quick Contact Pharma Clinical
Quick Contact Pharma Clinical


Quick Contact Pharma Clinical
Quick Contact Pharma Clinical
Quick Contact Pharma Clinical


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