How Clinical Research & Patient Care Flourish under Successful Clinical Operations
Clinical operations mark the cornerstone of a successful clinical trial and play a key role in providing high-quality patient care. Clinical trials are meticulously planned and are bound to an array of regulations and legal requirements. They are designed to ensure that investigational treatments can be closely examined.
At the same time, patient safety is held in the highest regard, while adverse events are monitored by the principal investigator and communicated directly to the study team.
Clinical operations encompass a multi-department cooperation that lays the foundation for advancement, innovation, and improved care outcomes. Clinical operations are credited with optimizing healthcare and developing new treatments with the goal of helping cure disease and offer novel solutions to patients and practitioners.
What Do Clinical Operations Constitute?
Clinical operations are the pulse of every clinical trial, building the foundation for successful execution through cross-functional and multi-disciplinary teams. Excellent communication skills, therefore, stand at the forefront of every new clinical trial.
Clinical trials are multi-faceted and require a lot of attention to detail from start to finish due to the significance of the manner of conduct. They constitute all tasks related to subject recruitment, diagnosing patients, conducting study procedures and visits as per the study protocol, and analyzing clinical data.
In-depth knowledge of pharmacokinetics and science are at the center of all clinical operations. Still, data management, patient safety, and adherence to both legal and regulatory requirements are further key aspects of a fluid process.
In order to accurately meet the inclusion and exclusion criteria of a clinical trial, physicians at various participating sites are in dire need of a detailed medical history for each patient.
This ensures providers are well-informed about subjects recruited for a study and identify only patients who have not previously been diagnosed with an exclusionary condition or have been treated with medications that would disqualify them from trial participation.
Communication among all treating physicians is critical in order to compile an extensive medical history. It also heavily influences the outcome of a clinical trial, as well as the validity of the clinical data and any conclusions drawn.
Clinical Operations in Clinical Research
In clinical research, the clinical operations department addresses an array of clinical and regulatory requirements. This applies to both the design and later implementation of a clinical trial. All sponsors, third-party vendors (like clinical equipment suppliers), and the sites are important players that contribute to the success of research.
While protocol development and study design fall on the sponsor, other crucial tasks include site identification and monitoring in order to ensure adherence to the study protocol.
The sites, in turn, being at the forefront of clinical operations, directly identify and manage study participants by researching a patient’s medical history and concomitant medication lists. This process may prove tedious and time-consuming, however, abidance by inclusion and exclusion criteria is imperative in identifying patients that truly meet trial requirements.
The principal investigator (PI) and any sub-investigators (Sub-I) are further expected to follow regulations and adhere to good clinical practice guidelines and of course the study protocol.
Data collection is one of the most important tasks the PI will oversee. Any protocol deviations require detailed documentation — and in some instances, sponsor approval. Therefore, it’s imperative that site staff thoroughly review visit requirements and adhere to the prescribed visit windows to ensure uniformity throughout the study.
Clinical operations at participating sites require the clinical staff to communicate data findings and protocol deviations directly to the sponsor while the investigator also holds a crucial role in clearly communicating study expectations to the patients.
The site also functions as a point of contact for any adverse events that occur during the study and addresses concerns about patient safety. The PI further needs to ensure that all participants sign a consent form at their screening visit and are offered ample opportunity to get their questions answered.
In summary, sites need to effectively communicate with:
- other treating physicians to collect clinical data on the subjects to ensure the protocol’s inclusion/exclusion criteria are met,
- the sponsor to convey clinical data and adverse events,
- and study participants to inform them about study requirements and safety concerns.
For many of the participants, clinical research offers a unique experience to patient care and access to investigational treatment — which in some cases may be the only reasonable option.
In addition, volunteers can make proud contributions to the advancement of society and the development of new medicinal treatment options, while receiving exceptional patient care and health monitoring at the same time.
Clinical Operations as Part of Healthcare
Clinical operations are vastly important, not only in the context of clinical research but also in the healthcare industry as a whole. As a driving force that pushes for innovation, trials offer solutions that can enhance the lives of patients, promote more effective treatments, and provide physicians with diversity and a multitude of options for their patients to choose from.
With patient safety at the heart of clinical research, investigational drugs undergo stringent regulations by the FDA (Food and Drug Administration) that ensure safety and industry standards have been met. FDA testing and requirements, therefore, promote patient care and strive for better health outcomes — offering patients significant benefits.
Quality control is another mechanism that consistently supports high industry standards and ensures that patient care deliverables are achieved and maintained. This can comprise chart audits and physician oversight or partnerships to verify clinical data.
However, clinical operations are also responsible for staying up-to-date on technological advancements and trends in the healthcare industry as the goal remains to yield high-quality patient care and increased patient satisfaction.
As with most industries, technological advancements help clinical operations leap forward, improve everyday processes, support clinical staff, and address patient needs quickly and effectively. This means that tools should fit the growing patient needs, aid in the decision-making process, and ideally help save both time and money — if possible.
Why Clinical Operations Remain Critical
The healthcare industry has long been guided by innovation and new technologies. Clinical research is of the essence in diversifying medicinal treatments and medical technologies, as well as providing novel tools to aid healthcare providers and patients — with the overall goal of advancing patient care and providing the utmost quality possible.
Communication among countless departments and outside offices remains a key clinical operations component. Understanding your patients’ backgrounds and past medical histories, procedures, and therapies is thus critical for clinical trial recruitment.
And we’re here to help you communicate effectively with other providers and conduct a detailed chart review of your patients prior to screening them for a new trial.
Vivlio Health offers providers a cloud-based platform that can integrate with all common EHR systems so that your clinical staff can access your patients’ full medical history, procedure notes, and discharge summaries.
An extensive review will help you decide whether your patient may or may not be a good fit for an anticipated trial. It also promotes patient safety and reduces the risk of screening failures, thus ensuring better success rates for clinical trials.