PHASE IIB - III CLINICAL TRIALS

To optimize clinical trials and reduce risks by remarkable expertise

  • Medical Writing
  • Regulatory Consultant
  • Clinical Monitoring
  • Project Management
  • Data Management & Biostatistics
  • Pharmacovigilance

Medical Writing

Medical Writing

Our scientific affair was expertise in PK/BA/BE study. Our experienced medical writers are capable to provide English, Chinese and Japanese scientific writing services to clients around the world. We ensure that the medical writer assigned to each project team has the required experiences to meet sponsor's needs.

Regulatory Consultant

The Electronic Comment Technical Document (eCTD) has been implemented in many advanced countries, such as the United States, European Union and Japan. Whether this is a product you want to bring to market and you need help executing your entire regulatory strategy or preparing your electronic regulatory submission, PPC can work with you to do what is necessary and provide professional and efficient solution to help you to move to the next milestone. We have extensive experience and assure our clients of top quality and complete confidentiality in all projects.

Clinical Monitoring

Our Clinical Monitoring team offers a high level of quality and consistency from first-in-human to Phase IV clinical study monitoring and site management, which involves drugs and medical devices. The clinical monitoring team will make sure all the CRAs are thoroughly trained in ICH GCP, and regulations, optimizing the professional services through the entire study period.

Project Management

Our operation team members have extensive experiences in managing clinical trials in various therapeutic areas. By using dedicated Project Management System, our PM team will provide our sponsor a suitable project timeline with timely status reports, control the site budget in cost-effective way, communicate in sponsor’s native language intimately, response to minimized culture difference barriers appropriately, and ensure the project achievements.

Data Management & Biostatistics

The integrity of clinical data is leading to the successful reporting of clinical trial results and affecting all clinical trial professionals. PPC has experience across a broad range of therapeutic areas and all phases of the drug/Medical device development process with capabilities of providing paper or electronic data capture (EDC) solutions to your data.

Pharmacovigilance

•        Clinical trial and post-marketing case processing

•        Medical review

•        Literature monitoring

•        ICSR and Periodic report s regulatory reporting

•        PV system set up/consultation

•        PV SOP/WI development

•        PV staff outsource

•        PV consulting

•        RMP, DSUR, PSUR and PBRER development/amendment

•        PV training

•        PV audit / Pre-audit preparation

•        Preparing or reviewing of safety data exchange agreement with           third parties

Unit 801-802, Tower A, China Overseas International Centre, No. 838 South Huangpi Road, Huangpu District, Shanghai

TEL: +86 21 5368-7600

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