PTKnowing the rules in clinical research alliances
Every new medicine is tested on people before it reaches the pharmacy, and each trial follows strict rules. The companies that run these trials work in partnerships. With 115 professionals who coordinate clinical research, the dissertation asks whether knowing the rules well makes the partnership better. Explained in 12 screens.
A new medicine depends on three organisations and two regulators
In Brazil, the clinical trial of a new medicine is run as an alliance: the pharmaceutical company pays, a specialised company runs it and a clinical centre receives the participants. All under the rules of Anvisa (the health regulator) and the CEP/CONEP ethics system. Tap each part and see what happens when a trial is judged to be outside the rules:
Roles from sections 3, 6.1 and 6.2. The dots going back and forth are our illustration based on Fraga and Bataglia (2022), cited in the dissertation: when the regulator judges a trial to be outside the rules, emails, meetings and coordination increase. CRO = contract research organisation (in Brazil, ORPC).
Knowledge of the rules travels in documents and in conversations
The dissertation measured regulatory knowledge by how much people in the company share what they know about the rules. There is explicit knowledge, written in reports and training, and tacit knowledge, found in experience and in knowing whom to ask. Tap a column:
Height = loading of each question (0 to 1) in the final model, Figure 11 and Table 20. Statements summarised from the questionnaire (Table 1); all begin with “People in my organisation…”, answers from 1 (strongly disagree) to 5 (strongly agree). Scale adapted from Wang and Wang (2012).
Relational capability has five parts, and changing the contract weighs the least
Relational capability is a company’s ability to manage its alliances. Schilke and Goerzen (2010) split it into five parts, and the dissertation used their 18 questions. Tap a column to see what each part means:
Height = weight of each part in relational capability (loading from 0 to 1), Figure 11; question loadings in Table 20. Definitions from section 2.1.
115 professionals who coordinate clinical trials answered
Supervisors, managers and coordinators at clinical research companies received the questionnaire by email, with help from an executive of the industry association (ABRACRO), and through LinkedIn, between October 2024 and January 2025. Each one thought of an alliance with a partner and answered 35 statements, from 1 to 5.
Sections 7.4, 7.6, 8.1 and 8.2.1. The 115 include the pre-test with 12 coordinators and the pilot test with 50 responses. Convenience sample; the minimum calculated was 68 responses. Analysis with structural equation modelling (PLS-SEM, SmartPLS 4).
Origin of the company’s capital, as stated by respondents (Table 7). The dissertation does not say how many different companies took part: there could be more than one person per company (section 7.3).
The dissertation made four bets about the path to performance
Alliance performance was measured by respondents’ satisfaction: with the results, the goals, what was learned and the profit. Before seeing the results, bet on each hypothesis. Your bets appear on the scoreboard on screen 11.
Model from Figure 1 and hypotheses from section 5. Mediation: the effect passes through relational capability. Moderation: relational capability changes the strength of the direct link.
Measured one at a time, both are linked to performance
First, the dissertation tested each link on its own. Where people share more knowledge about the rules, satisfaction with the alliance is higher. Where relational capability is higher, it is much higher. Switch the view:
Separate models from sections 8.2.3 and 8.2.4: β 0.504 (t 5.287, p < 0.001; R² 25.5%, Tables 11 and 12) and β 0.755 (t 13.969, p < 0.001; R² 56.9%, Tables 16 and 17). β = standardised coefficient: how much performance changes, in standard deviations, when the other factor goes up one standard deviation.
With relational capability in the model, the direct effect almost vanishes
When all three enter together, the direct arrow from knowledge to performance drops from 0.504 to 0.025, with no clear effect. The effect is still there, but now it passes through relational capability: those who share more knowledge about the rules manage the alliance better, and that is what goes with satisfaction. The dissertation calls this full mediation. Switch the model:
Full model from Figure 11 and Tables 21 and 22. Effect through the relationship: 0.641 × 0.738 = 0.473 (t 6.047, p < 0.001). Total 0.025 + 0.473 = 0.498, almost the same 0.504 as the model alone; about 95% passes through relational capability (our calculations). R² of performance: 56.9%; of relational capability: 41.1%.
More relational capability does not change the strength of the direct link
The fourth bet was different: besides being a path, relational capability would change the strength of the link between knowledge and performance (moderation). Move the slider and compare the illustration of the hypothesis with what the data showed:
If the hypothesis were right
What the data showed
Lines recalculated by us from the moderation model (Figure 12, standardised coefficients): performance = 0.730 × relationship − 0.017 × knowledge − 0.047 × knowledge × relationship. The interaction (−0.047) is not significant (p = 0.256, section 8.2.6). Axes in standard deviations, from −2 to +2. In the left panel, the slopes are made up.
Simulate an alliance with more knowledge of the rules
Increase regulatory knowledge and see what the final model predicts for relational capability and performance. Then lock relational capability: knowledge on its own barely moves performance.
Our calculation with the standardised coefficients of the final model (Figure 11): relational capability = 0.641 × knowledge; performance = 0.738 × relational capability + 0.025 × knowledge. Everything in standard deviations, relative to the mean of the 115 responses. It is a reading of the numbers, not a forecast for a real company: the questionnaire shows what goes together, not what causes what.
Two of the four hypotheses were confirmed
Knowledge of the rules is linked to relational capability (H2), and it reaches performance through it (H3). The direct link (H1) and moderation (H4) were not confirmed. Tap a column or a card to compare with your bet:
Final model with the 115 responses: H1, H2 and H3 from Table 21; H4 from Figure 12 and section 8.2.6. Height = β, without the sign. Confirmed = p ≤ 0.05, as in the dissertation.
Knowing the rules helps when the company knows how to work with the partner
For the author, knowledge is a strategic asset, but on its own it does not guarantee a better alliance: it takes the capability to manage it and fold it into the partnership’s routines.
For alliance managers
- Develop relationship skills in trial coordinators, besides technical ones, and create mechanisms to strengthen the partnership. (author)
- Learning from the partner and coordinating the alliance portfolio were the parts with the greatest weight (0.862 and 0.861).
For clinical research companies
- Seek partners whose regulatory knowledge complements their own. (author)
- Our reading: the study measured knowledge sharing within the company, and tacit knowledge (experience, knowing whom to ask) weighed more than written knowledge (0.930 × 0.868).
For rule makers
- Clinical trial regulation is complex and demands specific knowledge; the author argues for clear and efficient public policies and routines that make it easier to develop new medicines.
What this study does not say
- One sector only. Clinical research only; the author suggests testing other highly regulated sectors, such as aviation. · according to the author
- Other paths. Other factors, such as the capacity to absorb knowledge, may also act as the bridge. · according to the author
- Who answered. Supervisors, managers and coordinators, not top management; convenience sample, without knowing how many companies. · author and our note
- Perception at a single moment. Performance is respondents’ satisfaction, and everything came from the same questionnaire: it shows what goes together, not what causes what. · our note
- What was measured. “Regulatory knowledge” is the sharing of knowledge about the rules within the company; choosing complementary partners was not tested. · our note
Credits
SANCHES, Pedro Jhonathan Martins. O conhecimento regulatório em alianças de pesquisa clínica. Master’s dissertation (Business Administration), Mackenzie Presbyterian University, São Paulo, 2025. Advisor: Prof. Dr. Walter Bataglia.
Dissertation approved on 20 March 2025, with support from CAPES (the Brazilian federal agency for graduate education). Questionnaire analysed in SmartPLS 4. This version simplifies the work for the general public.