For each of the several full marketing application and IND projects we produce per year, our project teams provide:

• Early Timeline Development and Diligent Continuous Management

  Initially, we develop a full draft timeline early in the preparation process that includes all known milestones and identifiable interdependencies so that time and effort are used appropriately and efficiently throughout the program and various pieces of the submission are integrated appropriately. Then we monitor and update the timeline regularly with the goal of mitigating potential risks and delays to submission.

• Early Key Message Development

  We collaborate early in the preparation process to develop key messages in each discipline as well as overall risk-benefit considerations to guide drafting of documents across the application that strongly support a carefully crafted draft label. This includes taking global considerations into account if submissions will be made to multiple regulatory agencies.

• Gap analyses

  Rho performs early, comprehensive gap analyses for each discipline to identify any potential challenges in the presentation of the program. If determined necessary, we immediately begin any remediation to prevent submission delays. This includes evaluating existing data packages to assure submission readiness.

• Cross functional analysis planning

  Statistical analyses plans for crucial clinical data analyses are discussed and reviewed by a cross functional team that includes statisticians, regulatory strategists, therapeutic experts, medical professionals, and future document authors to assure that the planned analyses will allow for effective presentation of key messages and support for proposed labeling.

• Effective Presubmission Meetings

  Comprehensive, carefully considered Presubmission Meeting questions are crafted and prepared within an informative, high-quality Briefing Package so that responses from the meeting can effectively guide preparation of a successful marketing application.

• Staggered document preparation

  We draft sections as early as possible in the marketing application preparation process so that all receive the deserved focus. This allows focus late in the preparation process to be on crucial, late-stage documents such as clinical summaries and draft label development.

• Coordinated serial authorship of related documents

  Rho carefully plans document authorship so that more detailed documents are prepared first, followed by related summary documents – ensuring consistent messaging with appropriate supporting data across all related documents. For example, the Integrated Summary of Safety should be prepared before the Clinical Summary of Safety (Module 2.7.4), which should be prepared before the Clinical Overview (Module 2.5).

• Thorough early document review

  Review at all stages of document preparation by every key stakeholders across disciplines is critical. Detailed outlines can then be used to obtain early agreement on planned content and key messages within the clinical research.

Rho can support preparation of all portions of marketing applications, including:

• Module 1: Regional information for US or EU submissions

  Selection of regulatory communications for inclusion, preparation of an effective Reviewer’s Guide, preparation of draft labeling (including label, Medication Guide, Patient Information, Instructions for Use, etc.), preparation of REMS/Risk Management Plan.

• Module 2: Overviews and Summaries

  Preparation of all summaries for all disciplines, including clinical (Clinical Overview, Summaries of Biopharmaceutics, Clinical Pharmacology, Efficacy, and Safety), nonclinical (Nonclinical Overview and Nonclinical Written and Tabulated Summaries), and CMC (Quality Overview Summary).

• Module 3: Quality Data

  Preparation of modules effectively describing drug substance and drug product as appropriate to the product, with experience with drugs and biologics of various types and novelty, including cell and gene therapy products, and description of device components if necessary for a combination product.

• Module 4: Nonclinical Data

  Compilation of nonclinical reports and SEND datasets, and assistance with selecting supportive literature for inclusion, as appropriate.

• Module 5: Clinical Data

  Drafting of Integrated Summaries of Safety and Efficacy, if applicable; full statistical support for integrated statistical analyses; evaluation of all clinical study packages including datasets for submission readiness, with remediation available as needed; preparation of additional narratives, if needed.