Medical Affairs Services
Enhancing the scientific value of your commercialized products
Today’s Medical Affairs groups provide critical marketing and informational support for biopharmaceutical products and medical devices. Key Opinion Leaders (KOLs), healthcare professionals, regulatory agencies, and patients themselves have come to rely on the scientific and medical information provided by medical affairs professionals.
Medical Affairs plays a critical role in managing a product’s lifecycle by establishing optimal product positioning and differentiation, Phase IV research strategies, granting investigator initiated trials (IITs), as well as developing strategies for exploring new indications.
A key focus of any Medical Affairs department is the relationships with KOLs. A properly organized and managed IIT program is perhaps the strongest and most rewarding strategy for building strong KOL relationships.
A rigorous and transparent Medical Affairs strategy will:
Allow manufacturers to explore various therapeutic avenues and make sound research and development investments
Allow physicians to make educated decisions about new and developing treatment options
Inform patients and the general public about current patient outcomes and new treatment developments
Do you want to explore new therapeutic avenues for your commercialized product?
A robust IIT program allows manufacturers to provide cost-effective support and expand product knowledge by conducting trials that were not part of the company’s original clinical development plan. Additionally, properly executed IITs are one of the best ways to explore new treatment targets/indications, subpopulation effects, and therapeutic combinations.
Our Medical Affairs Services
Investigator initiated trials (IITs) present various challenges for clinicians and academic centers as the legal responsibilities, tasks and duties are the same as for conventional clinical trials, albeit with significantly lower budgets.
ethica CRO ensures that study logistics are not over-engineered and that study budgets are prioritized towards optimizing the probability of successful study completion. Importantly, to determine the optimal risk vs. budget profile, we provide detailed line-itemized budget options for your consideration.
Optimal planning from the onset is crucial in order to perform and deliver the consistent and high-quality data that scientific publishers and manufacturers can trust. Our biotech CRO can liaise with the Investigator, independently from the Sponsor or Granting Agency, and ensure that a properly constructed, ICH-GCP-compliant study protocol is developed, and that all necessary clinical trial logistics are put in place and properly managed. Alternatively, we can work with the Sponsor and the Investigator in order to transform the idea of an IIT into a larger Phase IV study.
Our medical affairs services include:
Phase IV Medical Affairs Studies
- Marketing Support Studies
- Proof of Concept Studies
- Product Differentiation Studies
- Explorative New Indication Studies
IIT Support
- Feasibility assessment and budgeting
- Clinical trial project management
- Regulatory affairs
- Medical writing
- Clinical study monitoring
- Data management
- Biostatistics
Our Medical Affairs Approach
Our mission is to protect the rights, dignity and welfare of the women, men and children who participate in research projects under our supervision. We approach medical affairs studies the same way as for full-scale clinical trials using our accredited research participant centered standard operating procedures (SOPs).
Our Medical Affairs Procedures
At ethica CRO, we ensure that IITs are supported by highly trained individuals who ensure a) proper study conduct, b) respect of timelines and deliverables, and c) appropriate data management/processing and biostatistical reporting. This support is delivered without jeopardizing Investigator independence or OIG (Office of the Inspector General) compliance.
Our team will work alongside the Investigator and key members of your Medical Affairs team (when appropriate) to develop study protocols and cost-effective study logistics. Upon study initiation, we will provide the research team with appropriate support in order to conduct the study, trouble-shoot problems, and mitigating risks.
We can also assist navigating through regulatory requirements (e.g., IND exemptions, etc.) as well as providing guidance to the Investigator to ensure that applicable regulatory obligations are supported and achieved.
Through our centralized statistical monitoring and data dashboards, we can provide options for real-time data access to Investigators as well as Sponsor personnel (if your SOPs allow). Depending on the study’s design and masking requirements, you can actually watch your data evolve over the project’s lifecycle.
ethica CRO not only maximizes the potential of your IITs’ being published in peer review journals, we also ensure that the Investigator has a very positive and rewarding experience, thus strengthening your KOL relationships.
Lastly, depending on how the Sponsor’s IIT process is structure, ethica CRO can contract directly with the Sponsor, or directly with the Investigator. If the later, the Investigator typically submits ethica CRO’s fees as part of the grant application.