TalentSource is the dedicated flexible resourcing department within CROMSOURCE, a high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries.
Since 1997 CROMSOURCE has been supporting pharmaceutical, biotechnology and medical device clients with outstanding clinical research and flexible resourcing solutions (through the TalentSource brand). At CROMSOURCE, we have vast experience with both large and small companies and have led many different approaches. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
CROMSOURCE, a privately owned, full service CRO, has two major complementary businesses: Flexible Resourcing (TalentSource Department) and Full-Service Outsourcing . By Acquiring MSOURCE in 2011, (headquartered in Belgium, which led to a change in name, so CROM became CROMSOURCE) the company not only strengthened its position in terms of expansion of infrastructure and capacity, but also added new services – Staffing Solutions – to the portfolio. Now CROMSOURCE continues to lead the way in providing flexible resourcing solutions.
We now offer a comprehensive portfolio of services, taking a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stage of a medical device development programme, through to provision of full services to a pharmaceutical company performing a large global study to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service, within budget and to timelines agreed.
CROMSOURCE has a rich history and the CROM founder, Oriana Zerbini MD, continues at the helm. We have grown steadily to become an organisation of over 500 experts with offices across Europe and North America with ongoing operations on a global scale, including the Middle East, Africa and South America. Our commitment to providing the right services to support our clients has seen us at the forefront of developments in the Industry; from pioneering the provision of contract staffing solutions in Northern Europe in the mid-90’s, to being early adopters of the ISO Quality Management certification in 2000.
Oriana Zerbini – Chief Executive Officer
Dr Oriana Zerbini MD specialised in Cardiology, Pharmacology and in Tropical Medicine and Hygiene at Padua, Modena and London Universities, respectively. She also received a Masters degree in Communication Skills from Bocconi University in Milan. Dr Zerbini spent twelve years working for a major international Pharmaceutical company where she was primarily responsible for leading clinical research programmes at national and international level.
Oriana is the Medical Director of CROMSOURCE, the company which she founded over 20 years ago. In this time she has lent her experience and expertise to many national and international clinical trials. These trials have been conducted for sponsor organisations of all sizes and at all phases of development. Her therapeutic area experience includes (but is not limited to) oncology, respiratory, cardiovascular, metabolic, rheumatology, CNS, infective disease, cardiology and vaccines. Oriana is also a key organiser in CROMSOURCE’s international development and over the last few years has established several European and North American strategic alliances.
Carlo Zerbini – Chief Financial Officer
Carlo Zerbini has more than 30 years’ experience in the finance field. Before joining CROMSOURCE, he gained experience in the Accounting and HR divisions in the previous working experiences. In 2002 he started to work for CROMSOURCE as Finance & Human Resource Manager Director; from February 2011 has been appointed as Chief Financial Officer (CFO) with the responsibility for the financial management of CROMSOURCE.
Troy W. McCall - Chief Operating Officer
Dr. McCall has more than twenty-five years of experience in the pharmaceutical and CRO industries, having worked for more than a decade each in increasingly senior positions in specialty pharma and life science services companies. He has a proven track record of success in leading and growing start-up, small, and medium-sized organizations. He has been a managing partner and/or CEO at four companies.
Dr. McCall has consistently been successful in building value through a disciplined business approach which includes, but is not limited to, cost rationalization and expense management resulting in industry-leading margins, hands-on and effective engagement with clients, FDA, and other stakeholders, active participation with the sales and marketing organizations to significantly improve top-line results, and top-grading talent at all levels. He has extensive experience with growing and transforming companies and developing successful, sustainable organizations.
In addition to his roles in pharmaceutical and life science services companies, Dr. McCall has served as an advisor to private equity firms to support their investment activities, both for potential new investments as well as providing guidance to their existing portfolio companies. He also served as a Senior Advisor to The Reagan-Udall Foundation for the Food and Drug Administration where he led multiple initiatives supporting the FDA’s mission to promote and protect public health. One such initiative was the Innovation in Medical Evidence Development and Surveillance (IMEDS) program, a public-private partnership comprised of a variety of stakeholders (FDA, regulated industry, academia, advocates, and others) with the goal of optimizing the way in which large observational healthcare datasets are managed to improve the safety of marketed medical products.
Simona Colazzo - Executive Director
Simona was awarded a degree in Biological Science at the University of Parma. She joined CROMSOURCE in 2002, starting her career in pharmacovigilance and then leading numerous national and international clinical trials in various therapeutic areas as a project manager. She then focused on quality assurance management, performing more than fifty in-house and on-site national and international audits. After eight years of progressive management experience she became Executive Director of CROMSOURCE, responsible for the successful management of the organization according to the company vision and corporate strategy.
Debbie Kent - Global Head of TalentSource
Debbie joined CROMSOURCE in 2016 as Global Head of TalentSource Life Sciences Department, the CROMSOURCE flexible resourcing Department. In this role, she heads up an international team, working directly with clients, coupled with the leadership of the Talent Acquisition Unit.
She has worked in the pharmaceutical industry since 1992 with prior roles as Head of Insourcing at one of the top 3 CROs, encompassing the Strategic Management and development of the Functional Services Department and as Head of Marketing, Business Development and Staffing in a niche data management and biometrics provider. Debbie has global management experience, leading a large management team throughout Europe, Asia and the Americas. Debbie studied marketing and business in the UK and is focused on client satisfaction and leadership excellence.
Kerry Dyson - Global Head Clinical Research Division
Kerry Dyson was awarded an MSc and PhD in exercise physiology from McMaster University (Canada) and Leeds Metropolitan University (UK), respectively. After a brief academic career he joined the industry in 1999 with Innovex Ltd (then part of the Quintiles group of companies). He then worked in roles of increasing seniority within operational clinical development at Innovex and Novartis pharmaceuticals until joining Catalyst Pharma Group (CPG) in 2003, becoming Head of EU Operations in 2004. Kerry’s focus then moved from purely operational activities to include strategic and corporate developmental responsibilities.
A large part of this role involved marketing and business development in across Europe and the USA. After providing significant support to the sale of the major part of CGP’s business to ICON plc, Kerry joined CROMSOURCE in 2008 with responsibility for contribution to corporate strategy, leading UK operations and business development. In 2011 Kerry became Director of Marketing and Communications whilst also retaining his role as Head of UK Operations. In 2016 Kerry leveraged his operational expertise to transition into another leadership role at CROMSOURCE, becoming Global Head of the Clinical Research Division. In this role Kerry is responsible for the oversight of all aspects of the delivery of clinical research services, ensuring the highest standards of quality, timeliness and accountability are delivered to CROMSOURCE clients.
Antoinette Torres Frankum - Executive Director Clinical Research Division
Antoinette has over 20 years’ experience leading teams and managing complex clinical trials in the Biotech, Pharma, and Medical Device Industry. At CROMSOURCE, Antoinette is part of the Executive team and has been instrumental in developing the US operations, as well as directing global clinical research activities.
Her passion for building high performing teams, improving the operational value chain, and being a part of the science to improve lives, drives her commitment to the industry. Therapeutic expertise includes but is not limited to: Rare Disease, Respiratory, CNS, Endocrinology, and Ophthalmology. Antoinette received her Bachelors Degree and Executive Management Certification from University of California, Los Angeles. She is a speaker and contributor at industry related organizations and conferences, and is a professional member of the Project Management Institute (PMI), Women in Bio (WIB), Healthcare Business Woman’s Association, Drug Information Association (DIA) and Association of Clinical Research Professionals (ACRP).
David Jackson - Director Biometrics Division
David Jackson earned his Statistics BSc. Hons. from The University of Glasgow and his MSc. in Statistics from the University of Sheffield. As a statistician he continues to take a special interest in the statistical challenges in complex trials where there is high dependence of multiple within patient observations (such as ophthalmic trials using data from both eyes). After a brief career in the service industry he joined the pharmaceutical industry in 2002, working as a statistician across all Phases for a major CRO. Spending a significant time with a biometrics specialist CRO and having always worked as a service provider has given David the insight into how full service and FSP models can support the pharmaceutical and medical device industries and of the importance of meeting our customer’s needs.
David joined CROMSOURCE in 2010 and as Head of the Biostatistics and Programing group oversaw the growth of the department and the streamlining of procedures to better meet the needs of our pharmaceutical and medical device sponsors. As Head of the Biometrics department David continues to support continual improvements to exceed our sponsor expectations. David is experienced across all areas of product development from statistical consultancy to FDA and EMA submission. David has represented our Sponsors at FDA (CDER, CBER and CDRH) and EMA meetings, interactions, audits and inspections and is comfortable advising and presenting on all biometrics aspects across a range of therapeutic areas. David’s skills are evident in communicating often complex biometrics procedures in non-complex language removing the fear from biometrics and opening the ‘black box’ for our sponsors.
David Dills - Director Regulatory Services
David joined CROMSOURCE in 2018 as Regulatory Services Department Director. He has more than 29 years’ of leadership experience in the biopharmaceutical and medical device industry within the regulatory affairs and compliance space. He has held positions of increasing responsibility with sponsors and service providers of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises.
He has worked with clients in ASEAN/APAC, EMEA and The Americas, and certainly with FDA and the global Health Authorities/CA’s involving a wide spectrum of product portfolios covering multiple therapeutic areas and medical specialties. He interprets the regulatory precedents and new legislation, understands the competitive landscape and conducts persuasive communications and meetings with the regulatory authorities while executing an effective regulatory strategy and path to regulatory approval. He is providing the global regulatory capabilities and regulatory intelligence support for clients, strategic and operational support for clinical operations, and collaborating with our internal stakeholders and business partners.
In addition, to being a professional member with industry associations, advisory boards, and a prolific speaker at industry events, he navigates the regulatory landscape throughout the product life cycle from premarketing, postmarketing to commercialization with regulatory oversight and regulatory crisis management. In addition, David is responsible for the development and deployment of new services in the Regulatory and Strategic Regulatory Consulting space and looks forward to providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones for our clients with proactive strategies to mitigate compliance exposure.
Margherita Mosconi - Chief Services Officer
Margherita Mosconi was awarded a BSc in Biological Science at the University of Pavia in 1990. She then joined a major global pharmaceutical company as a CRA and over the subsequent eleven years progressed through roles in national and international project management. In 2005 Margherita then joined CROMSOURCE as Clinical Research Operations Director overseeing the operational delivery of hundreds of trials at all phases of development.
From 2007 to 2016, Margherita has successfully overseen and expanded the global business development establishing many successful client relationships and strategic partnerships. She was responsible for driving the Company’s business growth leading the Business Development Department and the Marketing & Communication Department. After almost ten years spent in the commercial field, from March 2017 she drives the Corporate Communication contributing to share CROMSOURCE mission, vision and values. Moreover she is responsible for the development of new services in the Regulatory and Consulting area and supports the Senior Management in guaranteeing the efficiencies and effectiveness of the operational and commercial processes.
Silvio Severini - Managing Director of Techorizon
Silvio joined CROMSOURCE in 2001 as Clinical Monitor for Diabetic Clinical Trials, developing an expertise and robust experience of the Clinical Operations Processes. In 2004 he became Responsible for the General Services department and suppliers qualification. In 2005 he was nominated head IT Unit where in cooperation with his Team he started the development a customized tools for Pharma Industry (all validated according to the GAMP 4/5), Bank and Manufacturing market. In 2005 the first CROMSOURCE’ CTMS was delivered.
Expert Support – Flexibly Delivered.
TalentSource has clinical development in its corporate DNA!
With over 25 years’ experience of providing high quality services, we add real value to your work by allowing you to efficiently adjust the size of your team to manage peaks and troughs in your workload. We are equally comfortable acting in a functional service provider setting or in simply providing short and long term resources for your organisation. We specialise in supporting clients of all sizes, from global giants to virtual biotechs, whatever the size of your company, TalentSource will work with you closely, drawing on the experience of CROMSOURCE, to provide experts who are ready to make a difference to your work.
CROMSOURCE/TalentSource are experienced in resourcing full studies/functions or single project resources to be fully integrated into your teams. Importantly, we provide one single point of contact for each customer, to ensure total satisfaction, from new requirements to financial and operational management. CROMSOURCE is very proud of our history of providing dedicated management support for all client-directed staff, including people management, training, coaching and regular performance management reviews.
We know that we are not simply providing ‘staff’ or ‘resources’, we are providing experts – highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.
We recognise the importance of having a highly knowledgeable and professional team working on your projects, which is why we not only provide our clients with expertise, we also invest in training and developing our staff for the future, and this ensures that they are up to date with the latest developments and regulations within the clinical research industry.
Training programmes can cover soft skills, clinical research and often therapy area updates. In addition, our in-house training team are able to work closely with our clients to develop specific training which may be required by the project. By joining TalentSource, clinical research professionals are able to enjoy rewarding careers with support and development opportunities normally only associated with large clinical research companies. Annual performance reviews identify individuals’ skills and competencies and is the time to identify training needs and prepare a personal development plan.
In addition, we offer dedicated Line Management oversight to our staff, wherever they are located (client or in the CROMSOURCE Offices). They have regular management and coaching meetings and have objectives set and monitored. To further support our low employee turnover, we have developed comprehensive retention policies that go with our strong learning and development curriculum. Including “Pay for performance” compensation philosophy, achievement recognition and documented work-life balance policies Appreciated employees – satisfied and motivated staff – gives team stability and consistent operational delivery.
Quality management and quality assurance are of paramount importance at CROMSOURCE. Our commitment to Quality by Design is reflected in our certification according to the quality system ISO 9001 first achieved in 2002, when few others considered such accreditation important.
The quality system is thoroughly reviewed every year by external and independent auditors. In 2012, the ISO 9001:2008 certification moved to the multi-site approach and in November 2017 we successfully completed the certification transition to the newly revised ISO 9001:2015 quality management systems standard. Clients of CROMSOURCE can be assured that their projects will be delivered to the highest standards of quality.
Our established governance model, as well as the communication and escalation plan, is crucial to maintaining active oversight of the entire project. Once projects are operationalised, we put in place risk management, governance, communication, issue escalation plans. Governance covers the establishment of KPIs, analysis of systemic issues and this ensures that everyone is focussed on the Client’s objectives.
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