Contract research organizations (CRO) are outsourcing companies providing support to the pharmaceutical, biotechnology, and medical device industries on a contract basis. CROs are usually hired by companies in the medical industry called sponsors and perform tasks related to drug discovery, development, and testing.
Like any other niche organization, CROs have their own industry-related challenges. In this article, we’ll take a closer look at the niche and talk about some of the problems that these companies face.
How Do Contract Research Organizations Work?
Contract Research Organizations offer clinical trials and other research support services to their sponsoring companies. They support medicine-related organizations, governmental institutions, foundations, and universities. All these sponsors contract with CROs to conduct the trials on the outsource, without having to maintain a staff for these services, which often have limited duration.
CROs offer the following services: product development, clinical trials, laboratory services for processing trial samples, medical writing, regulatory affairs, post-marketing surveillance and other complementary services. With CROs, sponsors get their drug concepts approved and take them to the FDA premarket approval procedure.
Other benefits of contracting CROs include reduced time for development and announcement of a new drug to the market, saving on maintaining the personnel and facilities. On top of that, they also deal with a large amount of data, run increasingly complex clinical trials and deliver their services according to the regulatory affairs of a particular region. All these activities bring many challenges for these companies.
Challenges of Contract Research Organizations
High Quality Standards
CROs must meet a large number of requirements to be eligible to conduct their studies. First of all, they should follow global standard operating procedures (SOPs) and carry out systems audits to make sure all the employees follow them. All the staff involved in the trials should be trained to follow Good Clinical Practice (GCP), local regulations and other guidelines.
According to the GCP guidelines, the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Though, CROs must fulfill quality assurance and quality control requirements because their reputation and customer satisfaction depend on their ability to get their products approved by regulatory organizations.
Loads of Paperwork
Typically, sponsors and CROs agree to the terms of conducting the study. They define which materials and methods to be used in the study, what kind of data to be obtained, and any tests to be performed. The agreement and study results are usually recorded both electronically and on paper.
Upon completion, the study data is compiled, analyzed, and summarized. Medical writers create final reports in plain language that are usually stored and distributed online or on paper. All this documentation requires proper management in archives and online databases, so their maintenance requires a lot of human and physical resources as well as a high level of security and order.
Intricate Administration
Clinical research is an intricate procedure that requires numerous teams with various ranges of abilities and experience to perform various capacities. These include:
- Medically trained staff who create clinical reports and conventions including clinical research doctors, restorative consultants and others.
- Administrative staff that takes care of archives and other issues.
- Clinical operations group including clinical research partners, venture administrators, and clinical preliminary staff.
- Information management crew that ensures that the information gathered from clinical preliminaries is spotless and prepared for examination
- Biostatistics group that studies the trial data and decides whether the examination has yielded positive or negative outcomes.
- Medical writers who comprise reports and conventions in plain language.
- Quality assurance (QA) team that makes sure that CROs follow all necessary rules and standards
Not to mention IT team, administrative, finances, HR and other staff depending on the size of the company. To deliver maximum productivity and profit, all these departments require smart management and collaboration.
Data Security
According to a 2018 study, 19% of global data leaks are accounted for by healthcare organizations. But CROs take their data security very seriously because their sponsors are highly concerned about keeping their data private. While security breaches cause data leaks, impair R&D activities, and reduce trust toward the company.
To ensure data security, CROs develop their own sets of reliable tools. These usually include web-based document management systems with access control and electronic signatures, clinical trial management system (CTMS), electronic data capture (EDC), and more.
Accounting Challenges
CROs used to make rough estimates of the service costs because sponsors often placed changes orders which resulted in changes to third-party costs.
Under new accounting rules, CROs have to make more accurate cost estimates, including third-party costs, because it forms a basis for their revenue recognition. Accurate cost estimation is a pressing matter for CROs nowadays. The new regulations make their finances volatile, making CROs worried about a drop in share value on the stock market.
How Could CROs Deliver More Value to Their Sponsors?
Contract research organizations take their reputation seriously because it brings them sponsors and revenue. A reliable CRO sticks to the three main principles: it keeps to the budget, meets deadlines and delivers quality services.
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