Our SERVICES

CDISC & CSR Reporting

CDISC and CSR Reporting

Plus-Project has a talented team including CDISC Subject Matter Experts, Consultant Programmers, expert SAS Developers and PRINCE2 Practitioners. Our internal systems are fully audited and ICH GCP compliant, and use straightforward processes for specifying and delivering CDISC data, CSR output and regulatory submission deliverables. By combining extensive project management and development skills, our team deliver an outstanding quality product and enhanced service delivery.

CDISC and CSR Reporting

Plus-Project has a talented team including CDISC Subject Matter Experts, Consultant Programmers, expert SAS Developers and PRINCE2 Practitioners. Our internal systems are fully audited and ICH GCP compliant, and use straightforward processes for specifying and delivering CDISC data, CSR output and regulatory submission deliverables. By combining extensive project management and development skills, our team deliver an outstanding quality product and enhanced service delivery.

Case Study 1:

Plus-Project have provided expert CDISC, statistics and programming services to a mid-sized pharmaceutical company to deliver a priority compound to multiple regulatory authorities including the FDA and EMA. Services involved the review and acceptance of deliverables from multiple CROs, production of CDISC submission deliverables including specifications, datasets, define files and supporting documents, integration of multiple studies into ISS and ISE analyses, and development of standards and systems. Plus-Project also contributed to the rapid response and publishing teams.

Case Study 2:

Plus-Project consultants have provided statistics and programming services to a global pharmaceutical company, reporting a number of large scale and complex phase 3 projects in parallel, to compressed timelines, following customer standards and process. Working closely with the project team, we established a good working relationship and excellent communication strategy which was particularly effective during challenging periods.

Case Study 3:

Plus-Project played a pivotal role in a global CDISC Process and Technology improvement project on behalf of a mid-sized pharmaceutical company. Using PRINCE2 project management principles we worked alongside the Executive Management Team to create a cost-benefit analysis of various solutions including the latest new technologies, and subsequently lead the technical implementation teams.

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Our SERVICES

FSP
Flexible Resourcing
Statistics