Last Updated on May 30, 2023
Overview: Clinical Operations Support Services
Clinical trials involve comprehensive investigational processes to determine the safety and efficacy of novel drugs and diagnostic tools before they reach the market. From conception to execution, clinical operations are of paramount importance in the conduct of clinical trials. Before we delve into the significance and various aspects of clinical operations, we must understand the crux behind the growing scale of clinical trials. Factors, including non-compliance, decreased drug efficacy, aging, and tachyphylaxis, yield the demand to investigate novel potential modalities for chronic conditions. COVID-19, the global pandemic, reiterates an enhanced need to advance medical research and improve patient health outcomes through clinical trials.
This blog aims to cover all aspects of clinical operations delivered by Minerva Research Solutions in the form of full-range clinical trial management solutions. Read on to learn more.
What Are Clinical Operations?
A series of critical operations necessary for the execution of clinical trials are called clinical operations. It entails the planning, implementation, management, and execution of the clinical trial process. Clinical operations ensure that clinical trials are efficient, accurate, and compliant with regulations and industry standards. To begin with, establishing a skilled operational team well-versed in clinical operations is essential. Various clinical trial support service providers collaborate with clinical research organizations (CROs), pharma, medical and biotech companies to foster patient health outcomes. The clinical operations involve various stages:
- Study design
- Protocol development
- Site selection
- Patient recruitment
- Data collection and analysis
- Regulatory submissions
These clinical operations require coordination and collaboration among clinical research associates, data managers, biostatisticians, regulatory affairs professionals, and ethical communities to ensure the clinical trials adhere to Good Clinical Practice (GCP) guidelines.
Minerva: Providing Clinical Operations Support For Clinical Trials
Minerva, a rapidly growing clinical operations support provider based in Michigan and Texas, focuses on supporting streamlined clinical trials. Our team of experienced professionals works efficiently with CRCs to ensure the successful execution of high-quality clinical trials. We aim to provide end-to-end personalized solutions to our partners through real-time insights, operational expertise in clinical research conduct & innovative technology. We offer a wide range of efficient clinical trial operations management solutions as services to support clinical trials, including:
- Patient recruitment and retention
- Data operations
- Regulatory compliance
Patient Recruitment and Retention
Clinical trial recruitment is a crucial component of clinical operations in medical research. As clinical trial support providers, we develop recruitment strategies to support sponsors and pharma industries in achieving patient enrollment goals. Efficient recruitment and retention strategies are necessary to ensure clinical trial timelines do not exceed and the study results are meaningful and representative of the study population. We have boarded a patient recruitment team with extensive marketing and advertising expertise. They work on producing effective marketing campaigns for clinical trials while adhering to protocol requirements, GCP, and IRB guidelines.
The commonly provided clinical trial recruitment services to enhance enrollment goals include:
Digital marketing materials attract potential leads or study participants through web content. Materials include marketing and lead generation campaigns developed per specifics such as study design, inclusion-exclusion criteria, etc. SEO (search engine optimized) content such as blogs with focused keywords, and webpages are influential tools for enhancing patient recruitment in clinical trials. Utilizing social media and posting organic posts, paid ads are just as important tools in digital marketing that have shown increased enrollment and lead generation in clinical trials.
Digital media materials are delivered electronically through online channels such as social media, email, and websites. On the contrary, print media is another effective way to reach out to potential participants and keep them engaged throughout the study. Materials include flyers, brochures, posters, pocket cards, or informational cards. Distribution of print (paper) media study materials to a broader audience at clinics, seminars, offices, etc. have also shown enhanced patient recruitment and retention.
Websites Pages or Landing Pages:
Website and study pages influence eligible participants to participate in clinical trials. A website containing clear and concise study information, eligibility criteria, call to action, and study updates encourage engagement. It facilitates clinical trial sponsors and CROs to attract and retain a larger pool of eligible participants and generate leads.
Clinical Trial Data Operations
Our quality assurance team is a crucial part of our clinical operations. It ensures that the clinical trials adhere to the protocol and highest standards of quality and patient safety. Our data operations team functions efficiently to provide unbiased and error-free data to enhance our sponsors’ clinical trial databases. Data operations in clinical trials are usually performed by a quality assurance team and CRCs. It involves pre-screening support strategies, including a pre-screening questionnaire for clinical trials.
The data management services we provide to support clinical trials are:
Pre-screening of Potential Participants:
Pre-screening of potential participants is a critical component of patient recruitment. To identify the individuals likely to fit the study, pre-screening questionnaires are generated by our quality assurance team while adhering to the study guidelines. The eligibility criteria include age, gender, medical history, and current health status.
Clinical Data Management:
Data management services include the entry and management of participants’ data throughout the study lifecycle (from the first screening visit to the last follow-up visit). The efficiency and timeliness of data entry, as well as the prompt resolution of queries (within the next 24-48 hours) by our data operations team, ensures the accuracy and integrity of clinical trial data.
Electronic Data Capture:
The eSource templates are generated while adhering to eCRF guidelines provided by the CROs and sponsors. It helps streamline the data collection, reduce errors, and improve overall data quality during clinical trials.
Informed Consent Forms:
All study participants must fill in informed consent forms (ICF) before participating in a clinical trial. The ICF states the study’s purpose, procedures, risks, and benefits of the study drug, as well as the participant’s rights and responsibilities.
Regulatory affairs are essential in the conduct of clinical operations. It ensures that clinical trials comply with regulatory requirements and guidelines. Our regulatory team comprises experienced professionals who understand the complexities and challenges of navigating the regulatory landscape. We work closely with sponsors and investigators to provide them with flexible regulatory solutions unique to their clinical trial needs. Our team ensures that all necessary regulatory submissions are delivered timely and efficiently.
The regulatory responsibilities performed by our regulatory team include:
Ethics Committee and Regulatory Authority Approval:
Approval is required from the relevant ethics committee (IRB) and regulatory bodies (FDA) to conduct a clinical trial. It entails submitting a study protocol with other pertinent paperwork for evaluation and approval.
Reporting protocol deviation is a crucial part of regulatory affairs. Our regulatory team guarantees that regulatory agencies are made aware of any deviations that might affect the reliability, accuracy, or safety of the clinical trial data.
Efficient Adverse Event Reporting:
Any adverse events against the protocol and standard operating procedures (SOPs) provided by the sponsor or contract research organization (CRO) are crucial. The reporting is required to ensure the safety of study participants. Any unexpected or serious adverse event related to the investigational product is promptly briefed by our team. It involves collecting, documenting, and reporting adverse events to regulatory authorities.
Partnering with our regulatory team provides you the peace of mind that all legal obligations will be satisfied quickly and effectively. It enables the most stringent degree of compliance for your clinical trial.
Our team places the highest priority on patient safety and ethical conduct. Our clinical operations support services provided by our experienced teams are developed specifically to support clinical trials. Through the streamlined communication skills of our team members, we aim to keep all stakeholders informed and engaged with every detail of the clinical trial. To shorten the lifecycle of innovative therapeutics investigated under clinical trials, our patient recruitment team, quality assurance team, and regulatory team work closely to support clinical trials.