Special thanks to Dr Abhay Deshpande, Dr S Y Pandey and Dr C S Pandey for expert comments and edits.
Regulatory testing under GLP and globally harmonised guidelines in compliance with the global regulatory expectations, play a major role in the registration of the products. With the depth and spread of the ever-increasing regulatory expectations, advent of new scientific tools, it has become prudent for the corporations to choose the outsourcing model for evaluation of their products.
The CRO business model came into existence somewhere in the neighborhood of early 1970’s, after the safety and efficacy regulations became more stringent throughout the globe. To comply with all these regulations, the product manufacturers were lacking the resources in terms of expertise and knowledge. This problem statement was the foundation of the CRO business model.
CRO model was officially declared under the ICH definitions1 as "A person or an organisation (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions."
The concept became very successful since the CRO’s were specialised in their niche functions and they made the Research operations fast and affordable. Therefore, the companies were more focussed on product development, manufacturing, and sales functions to expand their businesses.
For three decades, till almost late 1990’s, the CRO business model was limited. The spill over from the company’s research programs was awarded to CROs. The CRO industry was based on Transactional or functional service providers, where the relationships between companies and CROs were limited to a ‘Supplier-Buyer’ relationship.
In Early 2000’s, increased data requirements and consolidations within various industries contributed to the exponential growth of CROs. This changed the CRO model into a ‘Preferred Vendor’-relationship with manufacturing companies. The late 2000’s onwards, the relationships became stronger and converted to a ‘Strategic Partnership’ model.
CRO’s in the Agrochemical Industry
The majority of the global regulators have made it mandatory for the data submitted to comply with the OECD GLP. A typical registration requirement includes 5 Batch analysis, Product Chemistry, Toxicology, Ecotoxicology, Environmental Fate and Metabolism, Bio-Efficacy and Residues.
Certain niche requirements like Endocrine disruption screening, Developmental and Reproduction studies, Neurotoxicity, Immunotoxicity, In vitro testing, LLNA, etc. are currently demanded by matured authorities in the US, EU, Japan, etc. Therefore, it is always preferred by the Regulatory managers to ensure that CRO is a ONE STOP SHOP, which can offer everything under one roof in the most organized manner. However, such CROs are far and few between! JRF Global, is one of such highly organized professional CROs which seamlessly blends professionalism, excellent quality and perfect science offered as a service package perfectly integrated, horizontally and vertically and offer everything under one roof.
The current Regulatory requirements are shifting from in vivo to in vitro studies which are based on the principles of 3R. The Scientific knowledge, experience, and expertise for in silico studies including QSAR and Read-across are gaining popularity. Higher tier Ecotox and Environmental fate studies are being increasingly sought after, by the global regulators to ensure environmental safety. The Regular Product Registration and re-registration requirements are also increasing day-by-day. In such scenario, the CROs role and responsibilities have increased tremendously. The task is made more challenging for the CROs, with the global harmonised guidelines as well as regulatory requirements.
The Regulatory Managers tend to outsource such studies with their preferred CRO, which is expected to meet the following basic needs: 1.Highest Quality GLP reports 2.Regular scheduled updates about the progress and results 3.On-time submission, 4.Impeccable scientific data presentation, discussion and interpretation ……..with all of them being mutually exclusive!
The pictogram (figure 1) given below, depicts a three step process of CRO selection.
While the Figure-I depicts the stages of selections, there several different subsets to be evaluated, which contribute to the selection of potential candidate CROs in each of the stages. Table-I highlights minimal tick-box parameters minimal tick-box parameters to be rated before entering into the preferred partner relationship.
Table-I : CRO selection Charter
All the above factors in the charter are self-explanatory and are evaluated independent of each other on the scale of 1 to 4, 4 being the highest. This charter certainly helps a Regulatory manager to eliminate the unfit CROs and narrow down the selection. Having said that the personal experience and comfort and resistance to change from existing service provider, could adversely affect the Regulatory Manager’s decision making process. A strong process of engaging the leadership team of the CRO to evaluate the depth and strength of their processes and systems, with a try-out followed by gradual increase in the quantum of work, works as a best practise. This time is well utilised to set up the “documented charter of expectations for both the organizations, ensuring a perfect relationship. This period is an investment for the Regulatory manager/team, which help them to have smooth ride in their regulatory journey.
JRF-Global: Your prefect partner for Strategic alliance!
JRF Global works with more than 400 clients across the globe. Several of our sponsors have given top rating on most of the parameters listed above. More than a dozen of them work on an annual program model, managed by the perfect program management tools at JRF. These tools cover everything from the sponsors’ predicted date of making the test substance available on site till the date of final report and summary of financial transactions in one single click database! This is further strengthened by ensuring that the sponsor specific “Relationship Charter” tuned to the needs of these premium sponsors are followed to the “t”! It includes details about the expected and actual timelines, broken down to the finer details like the major milestones for the individual studies defined in the beginning of the year, which aids the Regulatory manager with a clear calendar for submission, ensuring “no sleepless nights”. He/she just sends the samples at defined timelines and the rest is simply taken care of by JRF!
The CRO selection is a highly professional job for the regulatory manager. Let’s look at the following story….though fictitious…we all know this happens everywhere!
A certain John Smith, became the Head of Regulatory division in World’s leading Agrochemical Company. Joe, his boss called him and asked him to choose a right CRO for the new global registration program. John used the charter and evaluated many candidates and chose 5 CROs in the final round. Joe called Joh, and said, “John, The Company has invested US$ 40 mn for developing this product. Your responsibility is to make sure you choose a right CRO which can help us throughout registrations without any hiccups. However, the bigger responsibility on your shoulder is to ensure the reliability of the data because the entire world’s population will suffer if the product is not safe and CRO does not provide a right data. We are dealing with people’s lives, so ensuring mankind safety is your priority.”
In a nutshell, the message to take home is, that be cautious while choosing a right partner for your regulatory submissions.
Considering these anticipated challenges in the Regulatory arena, it is inevitable for a Regulatory manager to look for a preferred partnership with a CRO. Signing a well-planned annual program makes Regulatory managers’ task very easy to monitor all the projects smoothly without hiccups or unforeseen issues. Contact firstname.lastname@example.org for obtaining a free template of such annual program document.
1.ICH-GCP (E6 1.20)
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