SDC case studies - kn
Expedited Safety Review Meetings
A Clinical Partner Case Study of Safety Review Meeting Timelines
Case Study
Background
Statistics & Data Corporation (SDC) is an innovative biometrics services organization that has served the clinical research industry since 2005. We take pride in providing efficient, innovative, and effective solutions for our pharmaceutical, biotechnology, and medical device Clients. Our experienced teams take ownership of our Client’s needs and are positively engaged in their clinical projects. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/IWRS) expertise at our core, our services are scalable via our diverse and complementary strategic partnerships to provide full-service clinical trial solutions.
Collaboration and Expertise in Data Services
Collaboration and Expertise in Data Services Places SDC as True Extension of Client’s Team
SDC holds long range vision for building Client relationships based on...
Collaboration and Expertise in Data Services Places SDC as True Extension of Client’s Team
Case Study
Background
Statistics & Data Corporation (SDC) began working with an emerging biotechnology company in need of strategic scientific consulting for its early-stage clinical program. Within 18 months of initiating this relationship, SDC expanded support to include full biometrics. Over time, SDC developed flexible technology options based on various study requirements including adding a new technology solution preferred for their larger studies.
The teams continued to work strategically to implement preferred pricing as the volume of work expanded and SDC continued to meet the need for rapid turnaround of large volumes of ad-hoc work in support of regulatory feedback, program planning, study prioritization, etc. In this partnership, SDC has also worked flexibly with multiple different clinical CROs across the Client’s programs depending on preference for a given study. This binding relationship has withstood many changes and evolutions as both organizations have grown substantially over the course of the partnership.
A Post-Hoc Analysis Success Story: Providing Top-Tier Statistical Analysis Services
SDC is fully committed to providing clients with top-tier service throughout the entire clinical trial process. We also understand that additional support will sometimes be necessary once a study is complete to help guide our client’s product towards approval. Post-hoc analysis can be critical to the success of any clinical phase program and our experienced team is onboard to offer their support in cases like the following:
CRO Rescues Multi-Study Program Utilizing iMednet eClinical
Case Study
Background
Statistics & Data Corporation (SDC), a specialized biostatistics and clinical data management contract research organization (CRO), was recently approached by a biotechnology company to discuss a rescue scenario for two pivotal trials running in parallel.
Some of the unique challenges associated with this rescue program included:
- An aggressive transition schedule to maintain predetermined study enrollment and randomization requirements
- Rapid, dual study developments running in parallel
- The need for additional clinical operations support required to supplement the Sponsor’s internal resources
A Regulatory Support Success Story: Full Support and Representation
From pre-application through post-approval, SDC has extensive experience facilitating communication for our clients with institutional review boards (IRBs), the FDA, and other regulatory authorities. Whether filing a submission or preparing for an upcoming regulatory meeting, our experienced team will offer our full support and representation to help our client’s program succeed. An example of this support is listed below: