Early Development Services
Healthy Normal Volunteer
Early Development Services for early-stage pharma and biotech clients
In 2020, Lotus spun off a specialty division within the CRO to focus on Early Development Services (EDS). The EDS project teams have expertise across a broad range of clinical pharmacology studies including FIH, SAD/MAD, DDI, BE/BA, QTc/TQT, First to File, PK/PD, HAP, EEG, and Food Effect. Across the organization, our teams collectively have participated on nearly 100 SAD/MAD trials and bring a wealth of expertise to your overall clinical development plan.
The industry has been trending toward early signal detection, and complex designs continue to be the norm. Lotus has extensive experience running Phase I-IIa trials which include a normal healthy cohort, followed by dosing in patients suffering from various neurologic disorders. These trials tend to include biomarker measurements such as functional magnetic resonance imaging (fMRI), positron emission tomography (PET) scans, quantitative electroencephalography (qEEGs) and EEGs, cerebrospinal fluid (CSF) sampling, and other specialized procedures. Lotus is uniquely qualified to run these trials given its deep bench of early phase experts and its access to some of the country’s most successful Phase I units.
Our affiliated sites have the experience, facilities, and resources to conduct safe, precise, well-controlled clinical research. The sites’ accelerated enrollment is an integral part of our success. Each of our sites fast-track enrollment through a proprietary database and in-house subject recruitment resources.
Each of the services offered by Lotus are tailored to the unique needs of early clinical development, from our project planning, to monitoring strategies, to our use of standard CRF and T/L/F forms. Check out Our Services tab to learn more!
Lotus’ specialty Early Development Services (EDS) group was formed in 2020 to meet the need of our early-stage pharma and biotech clients. Our EDS team members work exclusively in early phase drug development and tailor services to meet the unique needs of these critical studies. They bring the specific study planning and clinical execution expertise across the following types of phase trials:
- Ascending Dose Cohorts (SAD/MAD)
- Drug Interaction (DDI)
- Cardiac Safety/TQT/QTc
- Renal and Hepatic
- PK/PD studies
- Food Effect
- First in human
- First to File
Specialties populations include:
- Tobacco Users
- Recreational drug users for assessment of abuse potential
- Hepatic Impaired
- Renal Insufficiency
- Adult and Elderly
- Low Testosterone
- Sexual Dysfunction