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International Clinical Trials

Starting Point

Regulators around the globe have placed increased scrutiny on the pharmacovigilance (PV) arena. As a result, there is more pressure than ever on PV experts to provide higher levels of surveillance, with more emphasis on targeted reporting of adverse events and safety signals. This increased scrutiny, which ultimately requires increased effort, also comes at a time of economic challenge, where doing more with less is the standard for all businesses.

In this environment, contract research organisations (CROs) have a more valuable role than ever in providing highly competent staff and services, enabling sponsors to meet the challenges that come from updated regulations from the European Union (EU) and the US Food and Drug Administration. This valuable partnership can be critical for sponsors – helping them meet high levels of quality and surveillance in a cost-effective manner.

Comparison Methodology

For the purposes of this article, a comparison was made between the costs of setting up a new PV department in the company (in-house) versus outsourcing the same functions to a CRO. While emphasis is placed on a full PV system for the support of marketed products, clinical trial support is also included, as the PV system is needed through the whole product lifecycle.

Comparisons were completed based upon the following assumptions and with review of the following basic areas:

● Low volume surveillance required (one to two products)
● No resources are in existence at the sponsor company

Key areas for department set-up
● Staff and overhead
● Department processes, procedures, workflows and organisational structures
● Systems (safety systems, call centre, distribution and other tracking)
● Training (including time and learning curves)
● Actual product surveillance activities including:
– Case processing (non-serious, serious, expedited)
– Information gathering (literature search, active surveillance)
– Medical oversight – to include the qualified person for pharmacovigilance (QPPV) and project management
– Signal detection and risk management
– Regulatory reporting (single case and aggregated)
– Medical writing support (labelling, core safety data sheets, aggregate reports, marketing materials, and so on)
– Medical information support, including product complaint handling
– Information distribution (Dear Healthcare Provider letters)

Department Set-Up

Not only do PV departments require the basics of any other department, but key components must also be in compliance with strict regulatory requirements and rapid global reporting timelines. There is little room for error.

Whether a PV department is established or newly developing, the daily tasks of surveillance and reporting must be maintained. This is especially difficult because incoming volumes cannot be controlled or delayed, often delaying set-up tasks and leaving sponsors in ‘crisis mode’ right from the beginning.

There are many components to any given PV programme, with a number of key areas – staff, processes, systems and training – that are needed when starting up a department to ensure quality and compliance.

Experienced Staff

There are three basic levels of staff experienced in PV who are required for a functional department: a qualified physician (who may also serve as QPPV in the EU); a drug safety expert (such as a nurse); and administrative/systems support.

Because of the stringent timelines for safety, even if low volumes are expected, a full-time staff needs to be present in each of these roles to ensure adequate coverage. This core team will also need to be expanded to include technical support (safety systems and data mining), medical writing, regulatory agents, and one backup staff per role (or backup staff that can handle multiple roles).

For the purposes of cost estimates, each staff member is assumed to work an average of 37.5 hours per week, having 30 non-working days per year, with 90 per cent utilisation when working. The average number of actual working hours per staff per year used for cost assumptions is 1,552.50 hours – 90 per cent of one full-time equivalent (FTE). No costs for staff recruitment are included.

Processes, Procedures, Workflows and Structures

The core of every department is operations. For operational activities to be efficient and compliant, they need to be governed by solid, well-documented processes.

Each PV department has a varying number of standard operating procedures (SOPs) by which it is governed. Based upon a basic set-up for both clinical trials (Phase 2 and up) through post-marketing surveillance, there are about 12 core procedures required. Assuming a typical creation, review and approval process time of 40-80 hours each, a total of three to six months of ramp-up time is required to complete all procedures.

Validated Systems

Within the PV arena, there are speciality systems required to meet regulatory scrutiny for safety surveillance. These include a validated safety database, call centre system, signal detection tools, case distribution and tracking tools, and access to global literature search databases.

Systems can be very expensive to implement. There are two typical models for this: a full purchase model, where the application is purchased, installed at the company and fully validated; and a hosted or application service provider (ASP) model, where the company ‘rents’ the system with purchased licences, but does not own the database.

Full purchase is the most costly model upfront, but does have lower annual fees after the initial installation. The ASP model is more costly on a yearly basis, but provides the advantage of low to no annual maintenance. The latter is also very reliant on the software vendor. This can be beneficial to reduce the internal cost of staff and support, but if the software vendor is not reliable, it can prove a compliance risk.

Training and Learning

For a start-up PV group, this involves online, self-paced, or even external training, all of which takes time and resources. For an established department, a new employee takes a minimum of three weeks to train, with an additional two to three months to work through a learning curve. For complex processes and systems, or management, this learning curve can be longer.

In this analysis, it is assumed that an FTE completing the required training (about three weeks full-time) and learning curve is 50 per cent productive (45 per cent utilised) during the first three months of employment.

Outsourcing Advantage

Whenever a new department is started or expanded, there are three major driving forces in the process: time, staff and costs. By managing each of these forces – and leveraging experienced support in these key areas – a successful, cost-efficient and quality process can be created and easily maintained. This is where outsourcing can provide sponsors with a significant advantage.

Time needs for a new or growing PV group can be broken into three main areas: time for ramp-up; time for case reporting to maintain compliance; and time until you are efficient and cost-effective. For the purposes of this analysis, these three areas can be reduced or eliminated by outsourcing the following tasks:

Time for Ramp-Up
This involves completion of core department SOPs, workflows and structures. With outsourcing models, ramp-up can be completed in weeks, not months.

Time for Maintaining Compliance
The toughest part of any new or transitioning project is keeping up with incoming work, while you set-up and acclimatise. Outsourcing enables completion of incoming work while in-house teams are established. It is also helpful during volume fluctuations – placing the resource management on the CRO to reduce the cost variations for short-term fluctuations or unstable volume periods.

Time for Efficiency and Cost-Effectiveness
Efficiency and cost-effectiveness are two things that are gained over time with process testing and improvement. Because CRO processes are time-tested, lean and proven, these two elements are built in from the start.

Qualified and Reliable Staff

Finding qualified and reliable staff is time-consuming and costly. Poor staff selection risks non-compliance with regulatory requirements, which can impact the product’s development or maintenance on the market. For the small pharma company, the recruitment process can be difficult, as the level of staff needed tends to be of a higher experience and educational level so that all levels of the process can be completed (for example, a physician may have to be hired to handle both medical management and full case processing, when normally this may be done by two different-level staff).

This is not always appealing to more experienced staff, and is also not the most cost-effective model. However, when growing PV departments, this is the model used out of necessity.

When outsourcing, all of the appropriate levels of experienced staff are used, which is not only more cost-effective, but also provides needed levels of backup for all staff. Seamless, continuous staffing coverage can be a struggle for a small company, and something which can also burn out staff who are on-call 24/7.

Investing in Systems

Investing in solid, validated systems is a major decision for any company. Most systems require a minimum of nine months to a year to work through the implementation, validation and start-up process. With costs from several hundred thousand to over a million US dollars, the ability to bypass this process by outsourcing to a vendor is a real benefit to any company with limited resources.

Comparison Assumptions

A detailed comparison is set out in Table 1.
The following assumptions have been made for this analysis:

● 1 x full-time physician
● 1 x full-time safety associate (nurse or equivalent science/medical background)
● 1 x full-time administrative assistant with technical ability for system management
● Overhead costs have been presented as a percentage above the base salary of the individual staff, and include costs such as building, supplies, benefits and bonuses for management-level staff
● For outsourcing, percentages of staff have been assumed based upon typical algorithms and workflows for volumes outlined
● Costs are provided for US or European staff; other hybrid models using lower cost regions may also be utilised, producing significant cost reductions

● Includes first-year implementation (installation and validation), as well as one additional year of annual maintenance for below volume and the following systems: safety database, call centre management system, signal detection tool, case distribution and tracking, and literature search engine

PV Task Volumes
● 300 reports (30 individual case safety reports and 270 non-serious/non-suspected unexpected serious adverse reactions reports)
● 60 x medical information requests
● 5 x product complaints
● Global regulatory reporting (32 reports)
● Weekly literature searches
● Medical oversight
● Monthly signal detection
● Aggregate reporting (1 x periodic adverse drug experience report, 1 x periodic safety update report format per year)
● 30 x distributions (Dear Healthcare Provider letters)
● Monthly project management/oversight

The comparisons made for the purposes of this article are estimates, as staff salaries, hourly estimates and so on can vary depending on current salary ranges, cost of living, benefits, overheads, and specific systems and processes required.

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About the author

Donelle Bussom is Senior Director, Drug Safety at ICON Clinical Research, where she provides PV and operational oversight for the Americas. After leaving clinical practice as a nursing specialist, Donelle gained 17 years of PV experience within CROs, consultation groups and the pharmaceutical sector. Her areas of expertise include safety database implementation, project initiation and rapid ramp-up, training and aggregate reporting.

Donelle Bussom
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