Clinical Data Management

Clinical Data Management

Our experience spans studies in the therapeutic areas of Oncology, Cardio-vascular, Respiratory, Urology, Auto-immune disorders and Medical devices trial. Because the outcome of a study is critically dependent on the quality of clinical trial data, our Data Operations teams work closely with other study stakeholders, from the beginning of a study in order to ensure efficiency in areas that will affect bio-statistical analysis and submissions.

In this way, we are able to fashion workflows right from the start to ensure minimal rework, which translates into assured results and greater cost savings for both parties.

Data Management Services Include

  • CRF Design
  • DMP Preparation
  • Database Build and Validation
  • Data Entry
  • Edit Check designing
  • Medical Coding
  • SAE Reconciliation
  • Lab Data Transfers
  • QC and QA reviews
  • Database Freeze and Lock
  • Raw Datasets generation
  • CDISC services

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The PPCE Advantage

  • Quality by Design: A proactive approach to issues affecting data integrity
  • Ease of Control: Single point contact until the end of a study
  • Global Standards: 21 CFR part 11, ICH-GCP and CDISC requirements are built into SOPs and updated at regular intervals
  • Therapeutic expertise: Experience in various therapeutic areas with a focus on oncology
  • Quality delivery: Regular in-house audits ensure quality and timelines are on track
  • Timeliness: High quality output and on-time delivery - no excuses!
  • Flexibility: Offers end to end services as well as FTEs; Has the ability to work as per PPCE or Sponsor SOPs as preferred; has teams skilled on a variety of data management platforms that include Oracle Clinical, Medidata Rave and eClinical OS.

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Vision

It is our mission to be a long term, ethical, global player in the field of Clinical Research Allied Services. We will ensure that all our customers have a high level of confidence in our services and that all members of our team achieve their true potentials. We envision equal and beneficial collaborations with all partners. It is important for us to make a positive impact on our planet, through the promotion of knowledge and awareness, the respectful use of resources, and by encouraging the up liftment of the less privileged.

We aim to achieve our vision by focusing on our core competences and through diligence to each activity in which each of us is involved:

Providing timely, accurate, secure and quality clinical data to our clients through our clinical data management services.
Providing value added services through our customized industry oriented programs to ensure the highest quality of human resources in the clinical Research Allied Services industry.
Providing quality assurance services through conduct of first, second and third party audits to ensure high levels of compliance in the industry.

Meet Us

SCDM on 09-Dec-2016

Come hear us speak: Friday, 09th -December-2016 Track 1: Implementing Risk Based Monitoring in
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SCDM on 10-Dec-2016

Come hear us speak: Saturday, 10th-December-2016 Debate session: Risk Based Monitoring- CDM vs. ClinOps-
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DIA Annual Conference 2016

DRUG INFORMATION ASSOCIATION 52nd ANNUAL MEETING PHILADELPHIA, PENNSYLVANIA, USA 26 June - 30 June,
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Outsourcing in Clinical Trials West Coast 2016

February 10-11 2016, San Mateo, California
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Outsourcing in Clinical Trials East Coast 2015

Outsourcing in Clinical Trials New England Boston, MA, September 16-17 2015
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SCDM India Conference

INNOVATIONS IN CDM - VISION 2020 December 11-12th 2015
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Outsourcing in Clinical Trials West Coast 2015

7th Annual Outsourcing in Clinical Trials West Coast United States of America, Burlingame 3rd
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News & Events

Our 11th batch of PGDCRDM in collaboration with Ruby Hall Clinic

Our 11th batch of PGDCRDM in collaboration with Ruby Hall Clinic will
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PPCE speaks at SCDM India conference

SCDM Our Executive Director & QA speaks on risk based monitoring at the
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PPCE Selects eClinicalOS(TM) for Rheumatoid Arthritis Trial

MORRISVILLE, N.C., Nov. 19, 2014 (GLOBE NEWSWIRE) -- PPCE selected the eClinicalOS
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Partners with Ruby Hall Clinic

PPCE partners with Ruby Hall Clinic to offer a Post Graduate Diploma
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