Clinical Data Management
Our experience spans studies in the therapeutic areas of Oncology, Cardio-vascular, Respiratory, Urology, Auto-immune disorders and Medical devices. 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
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.
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.
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