ClearPoint offers clinical trials management to local investigators for pharmaceutical and biotech studies in multiple disease sites. The Site Management Organization (SMO) has a thorough knowledge of the local physician investigators within a broad variety of therapeutic indications. The goal of ClearPoint’s SMO is to provide our partner sites with the resources and expertise to deliver high quality data, meet and exceed enrollment projections within a rapid timeline and achieve positive financial outcomes. This SMO offers services including: identification of new studies, site and study feasibility analyses, patient recruitment, data management, regulatory compliance audits and consultations and integration of submission and financial operations data.
Increasing costs, growing complexity and longer timelines are some of the most difficult clinical research challenges faced today by physician investigators. Working with ClearPoint’s SMO brings the expertise and resources to meet both clinical and business needs of the investigators as well as study sponsors by providing the following:
- Physician Investigators
- Deployment of an “ease-of-use” model
- Strategies for the efficient integration of clinical research into the healthcare workflow
- Access to cutting-edge treatment options
- Additional sources of physician referral
- Current study protocol, recruitment and financial information
- Diversified physician revenue
- Pharmaceutical Sponsors
- Organizational management
- Rapid study start-up
- Thorough feasibility analysis of client studies
- Ease of study start-up of prequalified sites
- Comprehensive, on-going programs including project management, financial management, education and training
- Network-wide patient matching
- Ability to match patients based on integrated laboratory and pathology reporting to physicians
- Organizational management
- Collaboration of Physician Investigators and Pharmaceutical Sponsors
- Standardized budget process
- Provides leverage and faster execution of contract negotiations
- Cost Management
- Timely execution and effective trial management brings cost savings to our clients
- Decrease operating costs to manage research activities at the site level
- Standardized budget process
- Investigators and sites are selected based on clinical expertise and ability to perform within ICH Good Clinical Practice(GCP) guidelines
- Strong internal audit process, ensuring high quality data
- High data integrity ensures repeat site selection for future trials
An Introduction to Clinical Trials
Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial.
After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
What is a clinical trial?A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
Why participate in a clinical trial?Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Where do the ideas for trials come from?Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
Who sponsors clinical trials?Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, voluntary groups, and pharmaceutical companies. Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
What is a protocol?A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What is a placebo?A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
What is a control or control group?A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What are the phases of clinical trials?Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test a new drug or treatment for the first time in a small group of people (20-80) to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies provide additional information including the drug’s risks, benefits, and optimal use.
Participation in Clinical TrialsFor those considering participation in a clinical trial, the following frequently asked questions are important in understanding the role of the participant and the unique process of clinical trials.
What happens during a clinical trial?The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Glossary of Terms
See glossary of terms related to clinical studies, clinical trials and medical research on ClinicalTrials.gov.