Clinical trials have become increasingly complex over the last few years. More data is available than ever, trial designs are more intricate, and there’s an increased focus on highly specialized patient populations. These factors, combined with the industry’s global reach, make modern trial execution challenging.
These challenges highlight the need for highly specialized services. Without assistance with tasks like eTMF management, data management, and pharmacovigilance, it’s easy to become overwhelmed. However, the right partner can make all the difference. Our new “niche CRO” services streamline processes, enhance compliance, and help you manage your to-do list more effectively.
Understanding pharmacovigilance and why it’s crucial for clinical trials
Pharmacovigilance (PV) is a key component of any drug or vaccine clinical trial. It involves collecting and analyzing data to identify potential safety issues that might put patients at risk. More specifically, this information is used to:
- Detect, assess, and understand the potentially negative effects of drugs or vaccines.
- Prevent adverse reactions.
- Improve patient safety.
- Educate patients and stakeholders.
Considering its importance, having a dedicated PV team is essential to mitigate risks and ensure regulatory compliance. Without a well-defined PV plan in place, the trial could even be deemed unethical and open the door to potentially severe legal ramifications.
The challenges of managing PV in-house
In light of these consequences, many biopharmas opt to manage PV initiatives internally. However, this can be a drain on resources. PV requires a dedicated team of experts, sophisticated technology, and robust administrative support, all of which can be difficult for small and medium-sized companies to achieve.
Furthermore, as trials grow in size and complexity, PV requirements increase, making it challenging for internal team members to manage the growing list of responsibilities.
Benefits of outsourcing PV to a niche CRO
To ease this burden, more and more biopharma companies are outsourcing PV-related tasks. This provides peace of mind and allows employees to focus on their core responsibilities, rather than taking on additional work.
At Harbor Clinical, we offer a full suite of “niche” CRO services. This approach packages essential services with specific technology provided by third-party vendors. Some of our most popular offerings include:
- eTMF Management & eTMF Hosting
- Pharmacovigilance and Safety Database Hosting (with Flex Database)
- Data Management and EDC System (with Viedoc or Medidata)
By outsourcing your PV needs to a specialized CRO like Harbor Clinical, you gain access to a host of benefits that can streamline your operations and boost efficiency. From centralized data management to cost savings, here are some advantages of consolidating your PV activities under one provider:
Single source of information
Partnering with a PV provider ensures all your safety data is stored in one place. You don’t have to worry about data silos or lack of access. Everything can be analyzed, tracked, and interpreted from a single source.
Expertise and consistency
Our dedicated PV team has expertise in all aspects of drug safety monitoring. There’s no guesswork or burden placed on your internal team members, who are already managing their own responsibilities.
Cost-efficiency
Building and maintaining an in-house pharmacovigilance team can cost hundreds of thousands of dollars or more. That doesn’t even account for the technology overhead needed to maintain a robust PV database. Outsourcing streamlines this process, helping you stay within budget.
Enhanced flexibility
As trials grow and change, so too do the PV requirements. Outsourcing to a niche CRO lets you scale services up and down based on the trial’s needs. This ability to adapt offers flexibility for biopharmas of all sizes.
Learn more about our niche CRO services
Managing PV needs in-house simply isn’t feasible for small and medium-sized biopharmas. Partnering with a niche CRO like Harbor Clinical alleviates this burden while delivering various benefits, including enhanced efficiency, reduced costs, and improved safety monitoring.
If you’re ready to simplify your pharmacovigilance processes, get in touch! Email us at [email protected] today to learn more about how we can support your clinical trial needs with tailored, efficient PV services.
