When deciding to work with any business partner, it’s essential to understand how well the two companies are likely to fit together. Naturally, (by default) one needs to know that the chosen partner has the required professional expertise, experience and resources to deliver to the task; however it’s also important to understand if there is a good cultural fit, as this can have a significant impact on the success of the working relationship.
With discovery at its forefront, the medicines and healthcare industry is constantly pushing the boundaries of science and technology; however, it is also required to work within a highly rigid regulatory framework to ensure the products it develops are not only effective and beneficial to the patient, but they are also safe.
In the context of pharmacovigilance, compliance is everything. Standards and regulations are paramount to ensure that safety issues are managed in a consistent and timely manner, whilst providing transparency of data to support improvements in patient safety levels in the future. However, each company will have its own internal methods for managing and processing PV data, which makes this a key area to focus on when considering outsourcing.
It goes without saying that the outsource provider must fully understand and operate within the rules and regulations; but it must also be capable of understanding and adapting to the particular needs of the MAH at an operational level. Flexibility therefore, is a key criteria in establishing how easy it will be to work within a partnership with another company and in determining the value of working with one partner in comparison to another.
An adaptable approach is necessary in order to develop a seamless pathway between the two sets of resources (client and service partner) whether that relates to the processes, technologies or the people who manage them on a day-to-day basis.
It is not uncommon for a service provider to offer a menu of services and service levels, (e.g. gold, silver or bronze), but all too often these are rigid and inflexible, meaning the client has to adapt to the ways of the service provider. Whilst there are (sometimes) acceptable reasons for and benefits to doing this, working with a provider that offers the ability to be flexible and is willing to adapt to your needs is optimal. Obviously this should not be at the expense of receiving genuine professional advice and guidance if your existing practices create risk.
When calculating the total cost of a service, if retraining your entire PV staff or re-engineering your existing processes is a mandatory parameter to establishing a contract, then it pays to look at alternative providers.
A service partner that truly adds value to your business will offer good levels of flexibility through a collaborative yet proactive approach. In doing so they will be able to deliver constructive recommendations based on a deeper appreciation of your working practices and day-to-day challenges, and your future aspirations as a business.
The maxim ‘Together everyone achieves more’ can ultimately be realised, providing both parties are willing to embrace the concept of working together, which sometimes means being ready and willing to be flexible, when required. The TEAM at PDS is all of these things, because we are passionate about helping our clients to achieve their business goals.
Working with PDS
Outsourcing is becoming an increasingly viable option for many life sciences and healthcare companies of all sizes. Whilst employing full-time staff is still common, more and more companies are realising there are significant benefits to outsourcing some, or even all aspects of pharmacovigilance to a specialist provider such as PDS.
The key benefits
There are many key benefits to outsourcing pharmacovigilance to PDS including, but not exclusively:
- Dedicated specialists in Pharmacovigilance
- Dedicated professional staff, trained to the most current PV standards and regulations
- Reduced operating costs e.g., no recruitment, training, pension, sickness or holidays to pay for
- Flexibility of resources – only pay for PV resources when you need them
- Diversity and broader depth of PV expertise and experience
Maintain an objective, professional view of your quality compliance, e.g., independent review of your SOPs, documentation and processes.
- A dedicated, validated and cost effective PV Database
- Reduced technology costs – no licences, validation, support or training fees.
Working with PDS means you have a highly flexible and trusted partner who adds value to your business through quality of service, remaining up to date with the latest regulations (such as ISO IDMP) and staff training, whilst providing an objective insight to your business’s compliance status.