Clinical operation is a wide terminology that covers an entire spectrum of clinical research that aids applying clinical trials in the best possible and practical ways.
It involves multiple touchpoints that interact with the range of people working simultaneously other verticals like clinical quality assurance, clinical science, biostatistics and regulatory affairs, data management, etc.
What is Clinal Trial?
Clinical trials are experimental or observational studies done on humans. A clinical trial is a type of research that studies a test or treatment given to people. It is preclinical research.
The supply chain management works as one of the essential pillars to drive such clinical trials, especially for the drug administration purpose.
There are plenty of factors that affect the entire chain of clinical trial supply such as temperature sensitivity, drug safety, and security, fulfilling HIPAA, etc.
Such factors can largely affect the cost of clinical trials along and this is why sponsors and CROs are pretty finicky regarding the need for clinical trial supply management.
Scope of work for Clinical Operations
Since the scope of clinical operations is wide and the clinical trial supplies are limited, so all the specifics considering possible nitty gritty must be set beforehand. This will require medical officers to address a set of questions on biomedical/behavioral intervention on humans that includes the following (but not limited to)
– The launch and availability of new vaccines
– Set of available treatments for patients under observation
– List of drugs available
– New medical equipment(s)
It is used to determine whether new drugs, diagnostics or treatments are both safe and effective as well as to study how safe and helpful tests or treatments are. Here is where patient registry database software comes to play for maintaining the necessary study records that states activities drug dispensation records, like case report forms, or even regulatory forms.
Medical examiners can then assess potential subjects’ eligibility by incorporating various methods including screening interviews, medical records reviews, and noting the patient-physician and patient-nurse discussion.
The clinical operations can also help Identifying problems in protocols such that investigators can stay informed regarding the problems. This also helps in assistance that escalates towards resolving an existing problem like protocol revisions, etc.
You need to know the following clinal operations to keep up with the clinical trial supply equilibrium:
- Operational strategies during the early stage of clinical development
- Recording possible misconduct, fraud, or errors in the clinical trials
- Risk management thru contracts that encapsulates well-informed consent, Subject Insurance & Indemnification, and injuries.
- Ensuring quality integration in clinical trials
- Application of risk-based monitoring methods
- Enabling project management platforms for clinical trials
- Translating documents of clinical trial documents with outcomes on the solution, challenges and alternatives
- Research and Development on streamlining clinical trials operations
- Recording and analyzing activities pertaining to the good clinical practices and readiness to inspect for improvements
Role of Clinical Trial Supply in Clinical Operations
A research study is required to conclude whether or not the newly introduced products for people like a vaccine, a new drug or medical device is safe or not. The clinical trial presents an observational study where the investigators monitor and closely observe the subjects with an aim to measure the results.
Such researches will have researchers distancing themselves from the subject to not actively participate directly in the activity. While on the other hand, the intervention study will require such investigators to give the subject a dosage of medicine or introduce other intervention for comparing the subjects under treatment to those devoid of any treatment.
Here, they gauge the change in the health of the subject and implication of medicines wherein the result can affect the clinical trial supply.
Technology too plays a vital role in providing necessary analysis tools to the researchers. The most basic one being the Spreadsheet, they are best put to use by most of the medical companies for managing their clinical trial supply.
These are not the normal spreadsheet but a rather complex one having that are tweaked over the years for researchers to let them forecast the supply required for a clinical trial.
Usually, only one or two key individuals are responsible for collating and managing such a vast and dynamic database which in turn helps gauging and binding, if necessary, the difference between clinical trial supplies manufactured distributed.
But then, such forecasting will require an experienced statistician to the device and implement correct forecasting methodology without involving any guesswork. Here, they try to save themselves as well since no one would want to be held responsible for the unavailability of study drug when required.
Therefore, implementing clinical trial software for the research, analysis, and prediction can bring accurate results for a clinical trial based on the clinical operations carried out. Rather than depending on one or two people, this software mechanism offers an ample amount of inputs for researchers that help them in defining, implementing and tracking the clinical trial results.
Even the Administrative personnel involved in clinical trials can use such application for finding and scheduling participants for clinical trial and hence find and communicate the gap in clinical trial supply offering faster turnaround for getting the right supplies in time.
This Clinical trial software helps to ensure both the quality of the data from the study and the safety of patients participating in the study.
Keeping the key clinical operations in the top, the entire supply chain management can work wonders for keeping the medical ecosystem in tandem.
The role of clinical trial management software is wide and deep enough to integrate all the other healthcare solutions like hospital management systems, laboratory information management systems (LIMSs), or Patient report and health analytics and data management solutions.
The product needs to meet certain specifications for it to get involved in the Clinical Trial Management system. This means, that even though you have identified and function clinical operations, supply products for the same must have relevant participants with the consent.
The supplies should be ordered only after thorough planning and tracking of clinical trial projects which includes milestones and deadlines.
The vendors also need inputs and therefore the medical practitioner with the help of fellow associates should be able to capture and analyze critical subject information during such trials.