About Us
By focusing on Indications prevalent in minority populations, and engaging minority physicians that practice in these indication areas, we believe our expertise in Site Management would help improve Inclusion and Diversity in clinical research.
Our Vision is to see, in the near future, significant improvement in Inclusion and Diversity of minority groups in overall participation in clinical research and drug development.
Our Mission, within the next 5 years, our mission is to introduce more minority Investigators to clinical research, see increase in the number of minority research participants, and to work with Sites in minority populated areas.
Our Services
Qualified Investigators
At Heika, we help Sponsors and CROs identify and manage qualified minority investigators and sub-investigators for clinical trials in the United State in diverse therapeutic indications. We work with new-to-research investigators and sites by providing related training, guidance, operational and administrative support.
Site Operations Management
Our team of experienced and highly trained clinical research operations team are dedicated to assisting out sites with:
- Identify Suitable Trials for Sites and Investigators
- Feasibility and Qualification Support
- Study Start-Up, Budget, and Contracting
- Regulatory Submission and Compliance
- Hiring*, Training, and Managing Research Site Staff
- Document development - Source, Research SOPs, Work Instructions
- Data Entry, Query Resolution, Audit Preparation
- Monitoring Preparation, Close-Out Preparation.
Patient Recruitment
Our dedicated recruitment team works with our sites to identify study targeted patient population in minority regions. By leveraging our community outreach, and by utilizing tried and tested print, media, and social media marketing strategies, we have successfully helped our sites to consistently meet their screening and enrollment projections.
Site-Centered Support
We work with our sites and investigators to:
- Analysis of protocol, Visit procedures, and clinical expectations
- Development and synchronization of informed consent language
- Complete trial budget negotiation
- Proper identification of financial responsibility
- Streamlined research compliance processes
- Comprehensive analysis of documents and filing processes
- Compliant claims processing, billing, and documentation
- Invoice Submission and Financial Audit Preparation
Trial Equipment Leasing
We are proud to lease study required non-specialized equipment, such as Freezers, Refrigerators, Piccolo Chemistry Analyzers, ECG/EKG Machines, Centrifuge, Digital Scales, to our sites to reduce financial and timeline burdens to them and to Sponsors. We ensure equipment meets Sponsor specification, provide annual calibrations, provided equipment training, and ensure return after study close out.
Sponsor/CRO Collaborations
We are proud to partner with leading organizations in the medical research and development industry to advance the field and bring new treatments and technologies to patients around the world. We intimately comprehend the challenges and nuances that sites face. Our experience with clinical sites has not only shaped our approach but has also equipped us with the insights to deliver unparalleled support to sites, CROs, and Sponsors.