Site Selection and Patient Recruitment Enhancement
Site selection and Patient Recruitment are well known to be key limiting factors in a clinical trial’s success. As a matter of fact, 50% of sites enroll either one or no patients and 80% of clinical trials fail to meet enrollment goals.
At Rolain Clinical Research Consulting, we take advantage of our multiple years of experience and our large professional network to identify the best recruiting sites for your study and the best ways to target your patient population of interest.
Clinical Trial Monitoring and Site Management
Clinical Trial Monitoring consists of verifying that each trial site involved in a clinical study follows the Study Protocol, Standardized Operating Procedures (SOPs), ICH GCP, and all applicable local regulations. More importantly, this follow-up process is performed to ensure participant's health and efficacy of the treatment during the clinical trial.
At Rolain Clinical Research Consulting, we are dedicated to offering our clients high quality clinical trial monitoring and site management services from feasibility through to site closeout. All our services are provided by highly qualified Clinical Research Associates (CRAs) with extensive clinical research and appropriate therapeutic area experience.
The Clinical Monitoring services we offer include (but are not limited):
- Training of Principal Investigators (PIs), Sub-Investigators (Sub-Is) and Study Staff Members (e.g. Study Protocol, GCP, Safety Reporting, IMP Management, etc.)
- Clinical trial oversight to ensure study protocol and all applicable regulatory requirements compliance
- Ethics committee (IRB/REB) and regulatory authority (FDA/Health Canada) submissions
- Accurate Source Data Verification (SDV) and Source Data Review (SDR) to ensure clinical data reliability
- Investigational Medicinal Product (IMP) accountability
- Site audits and inspections assistance
Clinical Project Management
Clinical Project Management consists of supervising clinical trials in order to ensure their success. For that purpose, Clinical Project Managers must be pro-active thinkers and have a great sense of prioritization.
At Rolain Clinical Research Consulting, we manage your clinical trials from start to finish by setting realistic study timelines, proactively identifying any potential future issues, and solving any challenges that may arise by implementing rigorous risk mitigation plans. All our services are provided by highly qualified Clinical Project Managers with extensive clinical research, appropriate therapeutic area experience, as well as in agreement with Study Protocol, Standardized Operating Procedures (SOPs), ICH GCP, and all applicable local regulations.
The Clinical Project Management services we offer include (but are not limited to):
- Budget oversight and forecasting
- Study vendors oversight
- Clinical Trial Assistants (CTAs), Clinical Research Associates (CRAs) training and supervision
- Clinical trial site staff support
- Study timelines follow-up
- Development and implementation of the different study-related documents
Medical Writing
Medical Writing consists of creating clinical trial related documents such as Study Protocols, Monitoring Plans, Investigator Brochures, etc. This process is of utmost importance in order to accurately describe a clinical trial to all involved parties, such as patients, clinical sites, and country regulatory agencies.
At Rolain Clinical Research Consulting, we develop your clinical study documents to support your clinical trial implementation. More specifically, we assist you with your Investigator Brochures, Protocol Synopsis, Study Protocols, and Study Protocol Amendments. We also take great care at making your Informed Consent Forms or your Patient Information Leaflets understandable by any future trial subjects while still being scientifically and medically accurate.
Cognitive Debriefing Interviews
for Patient’s Questionnaires
Cognitive Debriefing Interviews consist of testing a patient questionnaire that was translated to make sure that the translation process did not alter the way it should be understood by representatives of the target language population. Cognitive Debriefing Interviews generally involve 5 or more respondents who meet the age, gender, medical condition or any other criteria of the target language population. This linguistic process is of utmost importance as patients' misunderstanding could result in the collection of inaccurate medical data and thus, can potentially lead to the rejection of an entire clinical trial. This process is also required by the US Food and Drug Administration (FDA).
At Rolain Clinical Research Consulting, our employees are not only professional language specialists but also have strong medical and scientific backgrounds, allowing them to successfully conduct your Cognitive Debriefing Interviews. Moreover, our extensive database of potential respondents allows us to meet tight delivery timelines, as well as a target language population that truly matches the needs of your clinical trial.
Certified Clinical Research Professional (CCRP)
by CRA School
Phases of Clinical Trials
Quick overview of the different phases of clinical trials
Also known as ‘First-in-Humans’, they are the first stage for medical devices or drug testing in human subjects. Their primary purpose is to assess safety, and for drug trials specifically, the pharmacokinetics, pharmacodynamics, and tolerability. These non-randomized trials usually include a relatively small number of healthy subjects (typically 20 to 100) and can last up to one year.
The goal of this second phase of trials is to determine if a medical device or a drug has any effect or biological/therapeutic activity while continuing to perform Phase I safety assessments. These Phase II trials are generally randomized and conducted with a larger group of subjects who are affected by the medical condition intended to be treated (50-300). These trials can last up to two years.
At this point, the drug is presumed to have some effect and this clinical trial phase helps determine the effectiveness of the new medical device or drug. These Phase III trials are typically randomized and conducted simultaneously in different hospitals/clinics. They involve large groups of subjects with the medical condition of interest (300-3000) and can last up to 5 years.
Also known as ‘Postmarketing Surveillance’, they are part of a continuous safety surveillance process called Pharmacovigilance. The goal of the Phase IV trial is to monitor long-term or rare adverse effects of medical devices or drugs once they have been released for general sale. As a result, this type of trial takes place with a very large subject population (thousands and up) and over a longer period of time compared to Phase I, II and III trials. At this stage, anyone seeking treatment from a physician can receive the medical device or the drug.
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