Clinical excellence, with a human touch.
Study Design and Protocol Writing
A trial can succeed or fail based on the integrity and consistency of the study protocol, including the chosen endpoints. We understand the importance of focused study design and are experts in crafting comprehensive and well-written protocols.
Our study design team effectively and expertly focuses on the specific needs of the client and the trial itself. Through frequent communication and collaboration with our clients, our team works to understand all the intricacies of the project, including indication-specific measures that may escape a less indication-focused CRO. With a focus on accuracy and consistency, our team will work to ensure the study protocol makes sense both scientifically and logistically, which is a benefit to all parties.
Our study design & medical writing services include:
- Informed consent forms
- Clinical study reports
- FDA briefing documents
- Investigator’s brochures
- Abstracts, posters and journal articles
- Executive summaries for efficacy or safety
- Patient narratives
Site Selection and Feasibility Access
For all clinical trials, the careful selection and evaluation of investigative sites is critical for the successful completion of the trial within the budgetary and timing requirements of the client. Quality sites are also essential in ensuring the generation of high-quality clinical data. At Alira Health, we work with our clients to quickly develop detailed and indication-focused site feasibility tools, which allows us to ensure a robust rate of site qualification and increase the probability of approved sites which meet your expectations.
Moreover, we have profound industry experience and long-standing relationships with hundreds of study coordinators and investigators worldwide. Alira Health’s database of clinical sites active in pharmaceutical and medical device research allows us to target reliable, relevant trial sites known for solid accrual potential and good data quality in the relevant study population.
At Alira Health, we help you ensure study compliance, consistency across study sites and drive regulatory and clinical performance. Our physician and nurse-trainers have deep indication experience, allowing us to offer you both in-person and virtual training that is customized to each sponsor’s clinical trial protocol. We provide the knowledge and skills necessary to create customized training programs in support of your unique and complex clinical trial goals. Our training programs have been used in hundreds of sites both in the US and abroad, maximizing the success of clinical trials in a variety of indications.
Subject Recruitment & Retention
Recognizing that identification and enrollment of potential trial subjects are of the greatest importance to trial sponsors, the Alira Health team has a unique focus on creatively designing tools and methods for subject recruitment and, more importantly, retention of enrolled subjects and ensuring their compliance to the protocol. We work with each sponsor to examining its unique needs and create “outside-the-box” solutions.
Data Management and Biostatistics
Clinical trials require an immense amount of data collection. We have the experience to collect, organize, analyze, and present data in a clear, efficient manner. From choosing an EDC platform and designing logical EDC screens to ease sites’ data entry burdens, to developing a statistical analysis plan, to demanding and developing clear, concise TLFs, we leverage our indication-specific experience to guide you smoothly through the process.
Trial Management and Clinical Operations (US)
Our mission is to deliver effective, end-to-end resource planning, collaboration and training for your clinical trial.
We have the experience, drive, and the site, investigator and vendor relationships essential for today’s fast-paced study start-up timelines and complicated regulatory environment. Our dedicated team acts as an extension of the sponsor’s team and provides superior, seamless support at every stage of the development process. We care about and are committed to clinical trial success.
From study feasibility and site selection to study close-out, we deliver a holistic, well-coordinated and collaborative approach to produce a superior clinical trial environment.
Alira Health’s clinical operations support services include:
Timeline Creation and Analysis.
An accurate study timeline ensures the study begins on time and sites are initiated in a manner consistent with expectations. We work with each client to customize the study timeline, making pointed recommendations, where possible, to shorten the overall timeline, and providing indication-specific expertise to ensure a collaborative and personal relationship with both the client and potential study sites.
Feasibility, Site Selection & Qualification.
We work with clients to quickly develop a detailed, indication-focused, site feasibility questionnaire that allows for rapid and highly reliable site pre-qualification ensuring a more robust rate of qualification of sites and increasing the probability that approved sites will meet accrual expectations.
We have extensive and long-standing relationships with countless study coordinators and investigators at hundreds of sites with directly-relevant trial experience. In addition, Alira Health has an extensive database of clinical sites active in pharmaceutical and medical device research, many of whom have been active in previous studies managed by Alira Health. We don’t waste time cold calling sites looking for interest – we already know which sites are relevant, and better yet, which sites are known for reasonable accrual potential and good data quality in the relevant study population.
Site Management & Monitoring.
As a gateway to study participants, the sites are one of the most valuable assets in a clinical study. Alira Health works diligently to ensure site staff feel as though they are a part of the study team. By thoroughly knowing the study protocol and communicating with site staff frequently, we guide sites to the best performance possible.
Site staff learn quickly that Alira Health team members are well-informed, professional, and quickly available by phone. With the Alira Health internal staff handling site management, our clinical monitors are focused on source data verification. Alira Health stresses indication and protocol training for every CRA. In addition, we focus on team communication in order minimize monitoring variability and keep CRA turnover low.
Our services include:
- Collection, review, and approval of site essential documents.
- IRB/EC submission assistance.
- Set-up and maintenance of the TMF.
- Monitoring of site source data against the CRF/eCRF
- Monitoring of site regulatory documents
- Quality Assurance (QA) audits of clinical trial sites
The collection, assessment, and disbursement of safety information is an integral part of Good Clinical Practice (GCP) and is an essential component of a clinical trial. Whether it relates to pharmacovigilance services for a drug trial, or device safety services for a device trial, the Alira Health team understands the specifics and nuances which proper safety services so important in every trial. We work with our clients to understand the safety specifics of each trial and then implement a robust system for project documentation, data collection, and generation of all required regulatory and periodic reports.
For more information, please contact Harry.