Tepsivo is the most modern and only fully digital service provider that provides both full pharmacovigilance system and the necessary inhouse PV software. Still, Tepsivo may not always be the best option for all outsourcing needs. We are not afraid to tell you that if think there are better options available for a specific case.

For example, if you are a large corporation looking for a huge team for cheap case processing, you are trying to work around hiring-freeze rules by renting a temporary team member, or you are a service provider looking to expand your service portfolio by using another subcontractor, others may fit better.

Below we provide information about different types of service providers, how they operate and how to choose the right kind of vendor, that being Tepsivo or someone else.

All of the below is based on our understanding of the market and it is a presentation of our personal opinion.

What to consider when selecting a service provider?

There are several things you should consider before even starting the selection process for a suitable service provider. First things you need to clarify on your side are what activities you want to outsource and why you want to outsource these.

If you are unsure of the answer to either of these questions, it would be the best to clarify it with a colleague who is a subject-matter expert in the area, or you can always reach out to Tepsivo for a free 15-minute consultation.

Once you know the answers to “What?” and the “Why?”, you can achieve further clarity by writing down the answers to the below questions. This will be helpful information to the potential service providers you approach.

What is the scope of the activities that you want to outsource?

• Are you looking to outsource a specific activity for which you do not have internal resources for?
• Are other service providers or partners involved in the process?
• Or do you want to fully outsource the activity?

If your goal (the answer to “Why?”) is to lower your costs, do you want to achieve this by

• paying less per hour?
• improving the process and spend less time in total?

If you goal is to achieve higher quality and legal compliance, do you want to do this by

• improving the process?
• using highly qualified and expensive PV experts? (hint: not always the answer here)

When do you need the services to start and how long should the service continue?

These questions should be easy to answer.

Who will manage and oversee the contractor?

This should be someone who understands the outsourced task and has sufficient authority in your organization to make decisions when the contractor has questions.

What kind of qualification assessment process do you have? Will the chosen vendor meet your company requirements?

If you are unsure, you may want to consult your procurement and/or quality assurance team.

What processes do you want the service provider to follow?

1. Do you want the service provider to follow your processes?
2. Should the service provider have their own processes in place?
3. Is there a third party involved whose processes are being followed?

Once you have these questions answered, you can be very confident that you know what kind of service provider you need, and you are ready to start contacting companies to get proposals.

If you were not able to answer the questions, or you are still unsure from what kind of service provider you need, do not hesitate to contact Tepsivo for a quick consultation call.

Types of PV service providers

Below we have listed example information about different size companies that provide outsourced pharmacovigilance services, with estimated pricing, the pros and cons and general description of what kind of services they provide.

None of these opinions are a description of any company in particular (except Tepsivo) but are rather general descriptions of different types of companies.

Big companies – CROs and Big Consultancies

1.000 – 50.000 employees

Hourly rate: $200 – 500

Annual PV budget: $1 mil. – 20 mil.

There are several companies that fall into this category. This group includes companies from two main categories: clinical research organizations (CRO) and big consultancies. The main thing is that these are large organizations that have staff globally and the capability to recruit new talent quickly, if needed to meet the requirements of their clients. Such firms typically aim for large contracts with big clients. Given their size, they can typically afford to outsource services they cannot handle to a mid-size PV provider who is happy to provide the extra staff to the CRO while working within the CRO’s processes.

In PV, these companies would typically focus on the ICSR processing of tens of thousands of cases per year.

Pros:

• These large companies can usually provide any kind of service in any scale necessary.
• Fast recruitment and scaling

Cons:

• Prices and budgets look like they are from another world
• Contracts look like it, too: over-complicated and extremely rigid
• Processes are never tailored to your needs or even the needs of your type of company in general
• Majority of the services are either subcontracted to mid-size PV companies who have further sub-contracted them or the services are provided by off-shoring centers in regions with cheap labor
• Overall, these companies heavily depend on manual-labor intense work provided from offshore centers and charged at the rates seen in big economies
• Very rigid, service is the same today as it was 10 years ago

Mid-size companies

100 – 1.000 employees

Hourly rate: $150 – 300

Annual PV budget: $350.000 – 5 mil.

Mid-size companies that are concentrated in pharmacovigilance might have similar capabilities within some services as the large CROs and big consultancies. They probably even have better understanding and expertise than the larger companies and often they act as the main contractor of the larger consultancies.

The mid-size PV organizations usually lack the internal resources for labor-intense tasks (such as case processing) and they have problems scaling when needed. These firms also lack global presence and will subcontract most tasks that require global reach.

Typically, these companies are well-suited for supporting a similar portfolio of customers as the large CROs and consultancies as they operate on a similar business model, only at smaller scale.

Pros:

• Good range of services
• Their prices are usually lower than the big CROs’
• Better processes than large CROs
• Higher level of expertise than in large CROs

Cons:

• Problems with scaling on short notice
• Prices lower than large CROs but still on the high end
• More flexible than large CROs but still very rigid and service of today same as 10 years ago
• Technology is almost never used
• Motivated to spend large number of hours to justify a higher invoice
• Still heavily dependent on manual labor and compared to big CROs, less apt to scale up and hire number of resources whose work they rely on

Small companies

Less than 100 employees

Hourly rate: $100 – 300

Annual PV budget: $250.000 – 500.000

Small service providers can provide full pharmacovigilance for smaller license holders (orphan drugs, small biotechs, niche products etc.). In some situations, this is a perfect match. You can get the support from the leadership of the company and the level of knowledge and service are like nowhere else. The smaller companies are also suitable for partial outsourcing of PV activities or outsourcing services locally in one country or region. The prices of smaller companies are usually lower at least for some of the activities due to less redundancies and overhead.

The downside of the smaller companies is that they are usually led by a handful of truly skilled experts and if you are not among the first clients, you will not be receiving the continuous support of these experts but their subordinates or subordinates’ subordinates. Often in the smaller companies the differences in the level of skill and knowledge are even steeper than in the mid-size companies because of even bigger issues with recruiting and scaling. With smaller companies, it is also possible that the level of quality differentiates between the processes. The company might for example be a top performer in case processing, but their signal management process is sub-par, or vice versa.

Pros:

• If you are among the first customers, you will get great service
• Better prices

Cons:

• Problems with scaling and need for outsourcing
• Handful of highly qualified experts overseeing less qualified colleagues
• Big variability in the quality of processes and delivered work
• Typically focused in one area of few areas, almost never offering a full range of services globally

Freelancers

1-3 employees

Hourly rate: $100 – 500

Annual PV budget: Not available

Freelancers have little administrative overhead which is good for the prices if you happen to find a freelancer with the level of quality that you desire and an hourly rate you are willing to cough up. It is possible to find the highest hourly rates among the freelancers if you happen to stumble upon a seasoned industry veteran who is able to charge $500 or more for their services.

With freelancers you are always in direct contact with the leadership of the company so you can be sure that there are no issues with decision making and you always get the highest possible level of service.

Among the freelancers there is a high variability in the level of expertise, service, and pricing. They usually lack the central intelligence, true and tested processes, and routine of setting up contracts that you would get with the larger company types. If you are lucky, the service level is as high as it gets. If you are unlucky, you end up paying thousands of EUR for virtually nothing. You will have to have a good vendor qualification and management system in place to ensure that the freelancers meet your internal quality requirements.

There are several hundreds to thousands of freelancers available to choose from. This is a good thing if you have the capacity and processes in place to choose and manage vendors. However, it can be a challenge if you don’t.

Pros:

• Lowest prices per hour
• Quick decision making
• High level of quality
• Hundreds of freelancers

Cons:

• Highest prices per hour
• Low level of quality
• Vendor qualification and management required from the client
• Hundreds of freelancers

Why Tepsivo is different?

As a truly unique provider with a completely new approach to PV, we don’t really belong to any of the types listed above.

As already mentioned above, we aim to be as transparent as possible about our capabilities, motives, and pricing, among other things. We believe that being candid from the beginning is better for us in the end. In our consultation we give our customers honest advice about their service needs even if this would mean that we would potentially end up with a smaller contract or without a contract altogether. Our ways of working also ensure that we are quick to make decisions throughout the process.

Transparency is one of the key building blocks that we use as a foundation of our simplified and fully compliant processes. The blueprints of the processes are the legal requirements and our modern quality management system. We use tools such as the Tepsivo Platform and Tepsivo Safety Database to manage our employees and their activities. Tepsivo Platform gives you the complete oversight of all the activities while reducing the costs with simple automation and improving quality with better data management and centralization.

As a fully digital company with a unique set of tools and expertise unparalleled in the industry, we are able to utilize the largest network of expert companies globally while still keeping our administrative overhead low. Our partner network consists of the same individuals that would be doing the work if you contracted the work with any of the above-described company groups. However, there are two major differences:

1) Our tools and processes ensure a higher quality of work

2) The price is lower because the highly qualified experts have to spend less time with administrative tasks, and we need less admin overhead to manage the activities

Utilizing the modern pharmacovigilance software in combination with the largest contractor network available makes it possible for us to scale easily.

Conclusion

When choosing a pharmacovigilance service provider, the main thing is that you are satisfied and that you can be confident that you never fail an inspection. If you are not convinced that Tepsivo would be the right choice for you as a service provider based on the text above or something that you read on our website (or any other reason for that matter), please feel free to send us a message and we can have a quick chat to discuss your situation. You might be absolutely right, and Tepsivo is not the right choice for you, but we are more than happy to confirm that to you and maybe give a push to the right direction.