Clinical Development Support Services

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Clinical development consulting

With extensive experience on products across all stages of development, our team leverages our scientific commercialization expertise to optimize your clinical development strategies. Our team is experienced in:

  • Translational medicine
  • Optimizing preclinical data to support clinical outcomes
  • Formulation optimization planning
  • Clinical platform analysis and planning
  • Endpoint assessments¬†
  • Trial construct for labeling
  • Establishing tools for diagnosis and efficacy assessment in the real-world setting
  • Phase 4 planning
  • Scenario planning

Protocol development

Our team has extensive experience in working with our client partners to optimize protocols to achieve regulatory and commercialization goals. We work with you to ensure that your outcomes and statistical analysis plans achieve what is needed for approval and also support target product profile and phase 4 development plans. Additionally, we recognize that the design of the protocol not only defines the data that will come from the trial but also impacts the trial recruitment process. Powered 4 Significance will work with you to take all these factors into consideration to optimize the trial design and protocol development process.

Clinical study report (CSR) development

The timely development of accurate, ICH-compliant CSRs is critical to the appropriate filing and ultimate use of your data. The CSR, once complete, becomes the primary source for regulatory review and should be developed to minimize post-submission requests for further data clarification and analyses. We understand the key regulatory requirements for both integrated and abbreviated CSRs and can provide final reports that are quality controlled for accuracy, address all critical issues for regulatory review, and provide for ease of review once submitted.

Regulatory writing

Our highly trained and experienced team of medical writers can assist your team with regulatory document development and submission. They are familiar with the specific templates and guidelines that must be followed to submit trial information and results to the FDA. Our team works closely with data management and clinical operations groups to assist with the review and analysis of clinical trial data. They compile, write, and edit regulatory materials including INDs, NDAs, CSRs, investigator brochures, and SAE narratives. These are all created with ICH guidelines in mind and with fastidious attention to detail and accuracy.

Retrospective trial support

From trial concept through design, implementation, analysis, and reporting, Powered 4 Significance can help you with any of your retrospective trial needs. We are able to facilitate the collection of both protected health information (PHI)-inclusive and PHI-exclusive data, ensuring that all necessary data protection requirements are addressed. Additionally we are able to facilitate the participant recruitment process and can assist in the final analysis of the data and development of the study report that results, and provide recommendations for how the data can best be communicated.

Statistical analysis

Powered 4 Significance’s statistical analysis and planning capabilities can support a range of requirements. We can work with your team to develop effective statistical analysis plans for clinical datasets to ensure that your protocols provide you with the data you need. We work in platforms that are fully compatible with Pharma standards and have experience with data generated by ourselves, our client partners, or other entities to provide meaningful statistical data analysis.

Clinical registry implementation and analysis

Our staff can support your team in designing and building clinical registries that meet your data mining and analysis needs and help track clinical outcomes. The methodologies and tools we use can enhance coordination of registry development and implementation or can update an existing registry to meet specific needs. We can assist in the IRB or WIRB approval process, participant recruitment, contract negotiations, development, implementation, and registry data collection and analysis.

IDMC/DSMB coordination

Powered 4 Significance has extensive experience in managing the implementation of IDMCs/DSMBs. We will ensure the proprietary communication of trial data to IDMC/DSMB members, provide support to the IDMC/DSMB chair for documentation of meeting discussions, facilitate communication of queries/requests/recommendations to the sponsor’s representative, and facilitate necessary logistical support for the organization of IDMC meetings/communications. Our support for your IDMC/DSMB includes:

  • Recruitment and charter development
  • Management of queries and requests
  • Data transfer and storage
  • Documentation
  • Sponsor liaison
  • Logistical support

Scientific commercialization consulting

When it comes to scientific commercialization, the Powered 4 Significance team’s skills cover a vast range of functional areas of excellence including clinical development, regulatory, medical affairs, business development, training, and operations. Clients value our comprehensive grasp of research and clinical development issues as well as our broad understanding of the highly regulated pharmaceutical environment. We combine our scientific knowledge and commercial insight to navigate the complex pharmaceutical landscape, dissecting the underlying science and leveraging our experiences to improve organizational effectiveness and establish clear product differentiation in the market. All this is accomplished by integration and coordination with your medical, clinical, and commercial team members.