Strategic Consulting
Constella has the capability to lead and manage full clinical development programs. Our role can begin in the pre-clinical stage or at any period in the drug development continuum. We can oversee the preparation and submission of the IND/CTA, plan and manage the clinical trial program, and progress the compound through to NDA/MAA submission and approval. Many of our clients choose this turn-key approach as it allows them to concentrate their limited internal resources on other projects.
Clinical Development Plans |
We have extensive experience designing overall clinical development plans, outlining the requisite studies and timelines to help our clients achieve their end-goal in an efficient and cost-effective manner. Our goal is to assure that the development program not only meets regulatory requirements, but also supports the desired labeling claims for the compound. Our clinical development plans range from topline views of the required studies to detailed plans that include individual protocol synopses.
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Protocol Design |
Our staff has experience with all aspects of protocol preparation, from developing the initial study design to writing the protocol from a study outline provided by the client. Our experience includes protocol writing for Phase I-IV clinical studies, adult and pediatric indications, orphan indications, and other indications for which there is very little prior knowledge or experience in terms of study design. |
Opinion Leader Panels |
Our clients often utilize key opinion leader panels to review draft development programs, specific protocol designs, or to provide input into specific regulatory, clinical, or medical issues. Constella can identify, organize, and manage these advisory panels of clinical, regulatory, medical, and therapeutic experts. We can develop all of the pre-meeting materials as well as the discussion guides for the meeting. The opinion leader panels can be moderated by Constella senior scientific staff, a key opinion leader, or the client. |
Due Diligence |
Our due diligence and licensing supports licensing-in and licensing-out opportunities. Our scientific staff can assess the non-clinical, clinical, medical, and regulatory materials for the target compound to assure that they are scientifically sound and aligned with the client’s expectations. |
Non-clinical Support |
We have the capability to assist with your non-clinical strategy and program implementation. A primary goal is to assure that your toxicology package meets regulatory requirements and supports your clinical development program. We can prepare or simply review the non-clinical components of your regulatory submissions, including INDs/IMPDs/CTAs and NDAs/MAAs |
Chemistry, Manufacturing & Controls (CMC) |
We are able to assist with formulation development, manufacturing issues, and CMC documentation preparation or review. |
