ClinStat Consulting, LLC

Our vision is to conduct clinical trials better and more cost effectively than anyone else. We accomplish this by working with our clients to not only deliver the clinical trial effectively, on time and within budget, but also by leveraging our in-depth expertise to ensure the clinical trial is properly designed.

We believe there is increasing need for innovation, creativity and scientific expertise in clinical research, characteristics often synonymous with small Biopharma and hence, though we are proud to have a number of the world’s largest pharmaceutical companies as our clients, greater than 80% of our client portfolio is small Biopharma.

ACLIRES has performed trials for an international array of biotech companies as well as for some of the largest global pharmaceutical companies. With our broad access to patients and expertise, our aim is to rapidly initiate our client’s studies, even when a very special patient population is required.

Our services include:
- Early Phase Studies
- Late Phase Studies
- Recruitment
- Regulatory Affairs
- Monitoring
- Site Selection
- Scientific Services/Medical Writing
- Consulting
- Quality Management

Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services.

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As consultants for the pharmaceutical, biotech and device industries we know that teams assembled around product development and clinical trials need more than a competent project manager and top technology to be successful at delivering according to plan.

To be successful, project teams in the health industry need a leader, with a strong medical and industry background, that will inspire, coordinate their efforts, and act as a single point of contact or reference for all involved; sponsors, sites, CROs, data & safety monitoring committee, clinical endpoint committee, special labs, IRB, FDA.

Anabase, founded by two MDs with both clinical practice and industry experience, provides independent, dedicated, hands on, medical and regulatory guidance to your product development and clinical trial projects.

Hoosier Cancer Research Network, Inc., formerly known as Hoosier Oncology Group, is an independent nonprofit contract research organization (CRO) that specializes in early phase multi-center, investigator-initiated oncology clinical trials. Our studies are conducted through a nationwide network of more than 450 academic and community sites. Our highly qualified team provides comprehensive study management including budgeting, contracting, LOI submission, study design, regulatory and IND support, custom EDC development and validation, safety reporting, monitoring, site management, correlative management, data management, and support for publication.

Hoosier Cancer Research Network’s vision and mission is to form unparalleled relationships between academic, community, pharmaceutical, and biotech collaborators with the goal of advancing cancer research, education, and patient advocacy.

Research Dynamics is a Clinical Research Organization (CRO) that provides high quality, flexible clinical trial services, GCP training, and consulting to the pharmaceutical, biotech, device industries as well as to investigators and academic medical centers. We use innovative technologies, experienced research professionals, and a commitment to clients through product development to approval.

As a full service CRO, we provide dedication, flexibility, value, and a unique depth of experience and expertise.
Complex trials or first trials in an emerging company require this depth of expertise and insight to ensure successful trial completion. Our strength is in our expericenced staff especially in clinical trial rescue studies where we can start work within 1-2 weeks. Our specialty is complex or difficult studies where our focused attention is needed.

As a focused CRO we concentrate on providing our clinical trial core competencies from site identification through trial conduct to final clean data collection. These activities include site monitoring, site management, project management, GCP auditing, regulatory document management and remote EDC monitoring.

As a full service CRO, we provide “best-in-class” experts for regulatory services, data management, statistics, pharmacovigilance, medical monitoring, etc. Our Clinical QA audit staff can conduct on-site clinical audits or internal audits such as report audits and documentation audits.

With the company’s training foundation, we continue to provide training in GCP and other research topics for any clinical research professional. We have written books on GCP for investigators, coordinators and monitors. Our templates for “SOPs for investigator sites” have been sold for over 15 yrs.

Our consulting services include assisting start-up companies with their clinical development plans, providing advice on clinical trials and process and system consulting.