Clinical Research

Pharmatrial is a general clinical research support service  provider. We aim to provide high quality of service with technology-driven clinical research activities to pharmaceutical, biotechnology and medical device companies

 

Our Clinical Research Associates have the capabilities to design, plan and manage every aspect of a study with alacrity and proficiency.

 

Clinical General Support– Full Services

 

 

The clinical development plan is intended to provide a rationale for the clinical indications and clinical anticipated dose and/or operation setup. It is aimed to generate evidence based information for the product safety and efficacy as well as supporting the clinical studies.

Pharmatrial provides a broad range of services offering the full study management environment designed to make your trial a success. Pharmatrial has helped numerous clients successfully manage the development to clinical studies, enabling them to make effective and fast decisions about the safety and efficacy of their investigational product.

Phamarial has great experience and know-how in executing clinical trials from First-in-Human trials through Proof-of-Concept to Post Marketing Studies for a wide range of pharmaceutical, biotechnology and medical device companies.

We consist of a medical writing unit, clinical trial monitoring unit, data management unit and the clinical regulatory unit, operating in harmony to offer and deliver high level of support during the whole clinical research study stages to assure full compliance with ICH-GCP and other regulatory requirements, and constructing of the statistical and study report in a timely manner.

 

Our core CRO Service offers the following activities:

 

Medical writing unit assignments:

 

  • Clinical SOPs preparation (for start ups & Clinical trial units)

  • Investigators Brochure (IB) Preparation

  • Study protocol Design

  • Consent Forms Design (as well as Subject information sheets)

  • Interim clinical study report

  • Final study report preparation

  • Investigational medicinal product dossier (IMPD)

  • Investigational product Labeling (to fit local country labeling requirements)

  • Annual safety reports (SAE, SUSAR)

  • Clinical study presentations

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Clinical operation unit assignments:​

  • Investigational Plans preparation with company R&D and clinical teams

  • Preparation of all study log-books forms required for study management

  • Preparation of Investigator Site File (ISF)

  • Study research agreements & follow up reports

  • Study Budgets Preparation

  • Investigators Identification

  • Pre study site evaluation / selection

  • Site visits and monitoring  study documents

  • Organizing of study Initiation meeting

  • Support for CRO's  evaluation audits

  • Training study site teams

  • Translation of critical documents

  • Investigational product logistic communication

  • On going risk management & report

  • Constant study progress reporting to the sponsor/client

 

Data management unit assignments:

  • CRF or eCRF design

  • Randomization procedures

  • Preparation of statistical plan

  • Clinical data Management (including verification and query tracking)

  • Coding of AEs & medications therapy

  • Statistical analysis (including interim analysis)

  • Statistical report preparation

 

Regulatory unit assignments:

  • Regulatory submissions approvals & communication

  • Regulatory authorities submissions & dialog (see regulatory section for details)

 

 

 

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