GeoSera is a pharmaceutical consulting company specializing in the management and execution of high-quality clinical research trials. GeoSera has decades of combined, wide-ranging industry experiences led by President and Owner, John Carlos Diaz.
GeoSera has experience in all facets of drug development ranging from:
- pre-clinical drug metabolism and pharmacokinetics and toxicology
- clinical pharmacology and phase I clinical trials
- late stage, phase II through IV clinical trials
- post-marketing required and Investigator Initiated clinical trials within Medical Affairs
GeoSera’s Partnering Goals
Partnering with GeoSera allows for sponsor companies to delegate the oversight and execution of their pipeline to experienced clinical research professionals who excel at leading phase I-IV, post-marketing required and Investigator Initiated clinical studies, entire Clinical Development Plans, and in-house and outsourced study teams.
GeoSera has a small, dedicated team that can easily scale up or down to support all the operational, data management, medical writing, medical, and statistical needs of a sponsor Pharmaceutical or Biotechnology company. Sponsor companies can partner with GeoSera in confidence and delegate all operational and data management, vendor selection, CRO, budget oversight, medical monitoring, biostatistics and programming, regulatory document writing, clinical development, and clinical strategy to a motivated team of professionals who understand the macro goals of a product’s Clinical Development Plan while focusing the operations team on the micro goals of clinical trial execution.
Please contact us to discuss how GeoSera can partner with your company.
- Provide cost-effective clinical operations support and oversight to achieve positive trial outcomes within budget and timelines.
- Create and execute Clinical Development Plans from study start-up to database lock to facilitate bringing treatment to patients.
- Incorporate GeoSera’s vast experience to identify potential Clinical Development Plan risks and create mitigation strategies to proactively implement solutions.
- Lead internal and external clinical matrix teams to exceed corporate goals and timelines.
- Accountable for Key Performance Indicators (KPIs) of cross functional in-house and outsourced teams.
- Act as a contract recruiter, talent acquisition, and networking partner to fill the needs of pharma and biotech companies.
- Medical monitoring and medical oversight as well as Clinical Development and Strategy support.
- Draft protocols, ICFs, CSRs, IBs, and articles for regulatory submission.
- Data management and programming (CDISC-SDTM) support for query generation and resolution, eCRF creation, and site training of data entry.
- Communicate and oversee executive management team decisions to outsourced vendors, in-house operational teams, and research sites.
- Provide statistical support, power calculations and Statistical Analysis Plan creation/review.
- Accountable for the execution of CROs, outsourced service providers, and research sites deliverables during the conduct of clinical trials.
- Act as the sponsor’s voice at conferences, networking events, research sites, Advisory Board, and Investigator meetings.
- Networking partner to assist in staffing and provide resources to further drug development.
GeoSera’s Therapeutic Area Experience:
- Bipolar Depression
- Pain, Post-surgical and Acute, Neuropathic, Osteoarthritis, Breakthrough Cancer, and Diabetic Peripheral Neuropathic Pain
- Rare Kidney Disease
- Opioid Use Disorder
- Agitation in Alzheimer’s, Dementia, Bipolar, and Schizophrenia
- Endocrinology, Acromegaly, and Growth Hormone Deficiency
- Sleep/Wake and Narcolepsy
- Clinical Pharmacology
- Ultra-rare CNS disease
- Wound Healing