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Contract research organizations also known as clinical research organizations (CROs) have become essential in supporting research across clinical fields such as pharmaceuticals, cosmetics, biotechnology, and medical devices. They work to ensure clinical trials are conducted efficiently, ethically, and in line with Good Clinical Practice (GCP) standards. CROs started by providing research animals in the 1940s and 1950s. Over time, they have expanded their services to cover preclinical and clinical testing (Nestor et al ., 2022).  Key Functions of CROs: While services that individual CROs offer can vary greatly, the most common include product development and formulation, clinical trial management, data management services, and various other complementary services (Mew et al ., 2023). Product development and formulation CROs help businesses create studies that are specifically designed to assess benefits on what the company is targeting. To guarantee that the studies can yield accurate results, they create study protocols that specify the trial's design, sample size, and testing procedures. Clinical trial management CROs select participants with specific skin types, ages, and conditions relevant to the product. They then conduct rigorous safety tests, like patch testing, to assess any irritation or sensitivity. Efficacy testing follows, measuring the product's benefit to the skin and whether the product answers the skin concern (Horita et al ., 2014). Data management services They monitor and report all participant outcomes, clinical observations, and any instrument measurements. Thereafter, CROs analyze the data to evaluate the products effectiveness, safety and outcome. Benefits of CROs Some of the benefits of CROs include efficient management of projects, data, and resources, along with access to advanced technology. CROs offer insights into common issues encountered at clinical trial sites and provide guidance on how to address them effectively, improving trial operations (Nestor et al ., 2022).  Future of CROs CRO should prioritize state-of-the-art technology when conducting clinical research. They should support efficient and organized study startups, assisting with participant recruitment, and ensuring precise, well-organized site documentation. With advanced technology and streamlined processes, CROs reduce the operational burden on clinical sites, allowing for greater focus on patient-centered outcomes and research quality (Nestor et al ., 2022).  Conclusion Clinical Research Organizations are vital for ensuring that new products are both safe and effective. It is also really important to select the right CRO to conduct the clinical trial for a specific product. References Horita K, Tanoue C, Yasoshima M, Ohtani T, Matsunaga K. Study of the usefulness of patch  testing and use test to predict the safety of commercial topical drugs. J Dermatol. 2014 Jun;41(6):505-13. doi: 10.1111/1346-8138.12505. PMID: 24909212. Mew A, Smith DA, Cole J, Sadow C, Tirumani SH, Ramaiya NH. Role of Radiologists in  Contract Research Organizations (CROs). Curr Probl Diagn Radiol. 2023 Mar-Apr;52(2):77-83. doi: 10.1067/j.cpradiol.2022.11.013. Epub 2022 Nov 17. PMID: 36481295. Nestor M, Pariser D, Del Rosso J, Glaser DA, Goldberg D, Ablon G, Lorenc ZP, Santos J.  The Future of Contract Research Organizations in Dermatology and Aesthetic Research. J Clin Aesthet Dermatol. 2022 Sep;15(9):16-19. PMID: 36213607; PMCID: PMC9529076.

As microbiome research continues to grow, the number of contract research organizations (CRO) that fund, carry out, and oversee associated microbiome research, diagnostics, and therapies is increasing. Therefore, several important factors must be taken into account when choosing a CRO in order to guarantee safe and successful microbiome study, especially when it comes to microbiome profiling. The organization's adherence to scientific protocols, the staff's experience, and the quality of its clinical and research procedures should all be taken into consideration during the selection process.  Key Components to consider when selecting a CRO Before selecting a CRO it is important to clarify the goals of the study. By doing so, it is easy to narrow down the organizations that align best with the goals that need to be achieved. Once this has been clearly defined, the selection process can proceed. Research the organization and previous work that had been done It is always important to begin the selection process by doing some research on the organization and their expertise and focus area. Making sure that their focus area aligns with what is expected in the study. It is also crucial to look into their previous work to evaluate their history of successful trials, and completion rates (Messersmith, 2012). Selecting the appropriate patient population It is important to look into whether the organization recruits participants for the clinical study. A successful clinical trial organization makes the best use of the studies participants and budget. To do this, the organization needs to choose trials that fit well with the participant population, the trial type and phase. The participant pool plays a key role in how many volunteers can likely be enrolled (J Oncol, 2008). Conducting In-house studies When choosing a CRO, look into whether they conduct in-house studies or collaborative studies. Organizations with active in-house studies often have control, flexibility, allow for careful control of study parameters, and timely completion when carrying out the study.  Ethical and Regulatory knowledge Making sure a CRO maintains strong ethical standards and transparency is essential. Since human subjects and sensitive data are frequently used in microbiome research, ethical considerations are essential. Additionally, they must be knowledgeable about regulatory regulations, and adhering to FDA and other regulatory bodies. This is essential for guaranteeing the trial's integrity (Mandy et al ., 2015). Conclusion Selecting the right CRO is essential and should align with the company’s goals, interests, and values. In this fast-paced area of research, the right organization can enhance your contributions and help in advancing in microbiome science. At Sequential, we specialize in conducting in-house clinical research, ensuring that each study is tailored to meet your specific needs. We carefully recruit suitable volunteers for each study, adhering strictly to all ethical and regulatory guidelines to maintain the highest standards of integrity and safety. Our team is dedicated to customizing every aspect of the research process, from study design to participant selection, allowing us to deliver relevant and actionable results that align with your goals. By leveraging our expertise and resources, we aim to provide comprehensive support throughout the research process in the clinical microbiome study.  References Identifying and selecting a clinical trial for your practice. J Oncol Pract. 2008 Jan;4(1):27-8.  doi: 10.1200/JOP.0814602. PMID: 20859441; PMCID: PMC2793943. Mandy, Bowen., Otis, Evans., NC, Stephen, Terry. (2015). 5. CRO, TLF, SOP? OMG!: A  Beginner's Guide to the Clinical Research Organization.    Messersmith, E. (2012). How to Select and Oversee Contract Research Organizations.  Global Clinical Trials Playbook, 39–55.  doi:10.1016/b978-0-12-415787-3.00005-9

Clinical trials are crucial for driving innovation and improving products in the personal care industry. They provide a structured framework to evaluate the safety, efficacy, and performance of new formulations, treatments, and skincare technologies. By participating in these trials, individuals contribute to advancing product development, ensuring better solutions for future consumers, and gaining early access to cutting-edge personal care innovations.  Phases of a clinical trial A clinical trial is a structured process designed to evaluate the safety and effectiveness of a product. The process consists of several phases; Phase 0: Initial testing is conducted to assess the product's safety and functionality.  Phase 1: Around <50 healthy subjects are recruited, to assess the product's safety on human skin.  Phase 2: Recruiting around 5-100 patients, to evaluate the product's effectiveness and confirm safety for its intended use. Phase 3: More than 300 patients (up to 3000), to validate safety and efficacy in a diverse population.  Phase 4: Monitor the product's performance and safety after its commercial launch, to identify long-term effects, rare reactions, or opportunities for product improvement. Each phase has a specific purpose and is categorized accordingly (Kandi & Vadakedath, 2023). Importance of evidence-based practices Clinical trials supports the importance of evidence-based practices, ensuring that formulations are rigorously tested for safety, efficacy, and measurable benefits.  Efficacy validation: Clinical trials play a crucial role in confirming the effectiveness of skincare products. For example, studies have demonstrated notable enhancements in skin concerns such as wrinkles and hydration levels following the use of specific formulations, like peptide serums (Draelos, Kononov & Fox, 2016). Guiding clinical standards: Data from clinical trials contribute to the development of dermatological standards and treatment protocols, enhancing patient care and outcomes (Kottner et al ., 2019). Diverse participant group: In clinical trials it is possible for researchers to recruit a broad range of participants, including adults and children, for in-depth studies.  Focusing on specific conditions: Clinical trials can focus on common skin concerns, such as aging, acne, and dermatitis, enabling targeted research that directly addresses the needs of particular groups. Combination treatments: Research frequently investigates the effectiveness of combination therapies, which can improve treatment results. Clinical trials have shown that multi-ingredient products can greatly enhance various skin attributes, including texture and tone (Herndon et al ., 2015). Targeting microbiome: By analyzing participant’s skin microbiomes, researchers can identify specific strains that may be beneficial for individual skin types (Theodorou et al ., 2024). Conclusion In conclusion, clinical trials play a crucial role in confirming product effectiveness, ensuring safety, and supporting evidence-based practices. They drive innovation, comply with regulatory requirements, and enhance patient outcomes, making them an essential aspect of research and product development. References Draelos ZD, Kononov T, Fox T. An Open Label Clinical Trial of a Peptide Treatment Serum  and Supporting Regimen Designed to Improve the Appearance of Aging Facial Skin. J Drugs Dermatol. 2016 Sep 1;15(9):1100-6. PMID: 27602972. Herndon JH Jr, Jiang L, Kononov T, Fox T. An Open Label Clinical Trial of a Multi-Ingredient  Anti-Aging Moisturizer Designed to Improve the Appearance of Facial Skin. J Drugs Dermatol. 2015 Jul;14(7):699-704. PMID: 26151786. Kandi V, Vadakedath S. Clinical Trials and Clinical Research: A Comprehensive Review.  Cureus. 2023 Feb 16;15(2):e35077. doi: 10.7759/cureus.35077. PMID: 36938261; PMCID: PMC10023071. Kottner J, Hahnel E, El Genedy M, Neumann K, Balzer K. Enhancing SKIN health and safety  in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial. Trials. 2019 May 29;20(1):302. doi: 10.1186/s13063-019-3375-7. PMID: 31142364; PMCID: PMC6542085. Theodorou IM, Kapoukranidou D, Theodorou M, Tsetis JK, Menni AE, Tzikos G, Bareka S,  Shrewsbury A, Stavrou G, Kotzampassi K. Cosmeceuticals: A Review of Clinical Studies Claiming to Contain Specific, Well-Characterized Strains of Probiotics or Postbiotics. Nutrients. 2024 Aug 2;16(15):2526. doi: 10.3390/nu16152526. PMID: 39125405; PMCID: PMC11314542.

At Sequential, we have developed a complete end-to-end solution to support microbiome R&D, formulation support and claims support. In 2019, we launched the world’s first at-home skin microbiome test kit (here) through Sequential Skin, and since then we have developed our B2B offering under Sequential (here). Sequential is formed by an award-winning team of scientists that is leading the way in microbiome analysis and detection: we are the first skin microbiome company to carry out in vivo testing (testing on the human skin) via an end-to-end service – from consultation, testing kits, to analysis and results, post-study consultation including claims substantiation and “Maintains the Microbiome in vivo” certification, as well as formulation optimisation. To date, we have analysed over 12,000 skin microbiome samples, deriving an AI-driven platform to improve formulation design, through working with 30 personal care, and skincare companies – such as Johnson & Johnson, Arcaea, Walgreens Boots Alliance, Clinique La Prairie, Vavin, and the Wella Company. Our microbiome technology is backed by some of the world's most prominent investors such as Metaplanet, Scrum Ventures, SOSV, Genedant, Ben Holmes (ex. Index Ventures), Innovate UK, and we are a resident company of Johnson & Johnson Innovation – JLABS. Sequential officially launched in March 2022 (here) and since then we have developed scalp, oral, and vulva microbiome testing kits as new products. We are headquartered in London UK, with testing labs in NYC and Singapore. Why is Sequential innovative? Sequential is developing first-in-class innovative microbiome solutions for the cosmetic and skincare industry. Since conception in 2017, we’ve launched first-of-its-kind products to help drive forward and advance R&D on the human microbiome. The human skin microbiome is incredibly complex and relies on a systems biology approach to understand the presence, function, and relationships between microbes on the skin. In medical research, in vitro experiments have been used for the past century in understanding the basic function of the cell, however, they often fail in translating what's really happening in – or on – the human body. In the context of the skin microbiome, this is because the microbe behaves very differently when they’re taken out of their natural environment – and network with other microbes and biofilm. The only way to test a specific species or strain of microbe is to test it within its ‘real-world’ context – or in vivo. This is where the innovative solutions of Sequential come in. We have developed rigorous experimental designs for longitudinal studies that allow us to measure the specific amount of micro-organisms using qPCR, giving us quantitative information on species and strain level of over 20+ microbes found on the skin in vivo. By testing at several time points over 2-4 weeks of product usage, we can have confidence in how the skin microbiome is truly being affected. Our database on the skin microbiome and products are extensive, which allows us to have a clear understanding of how products and ingredients are having an effect on the microbiome. Our Sequential Patch is a skin microbiome testing solution that can be employed to ensure more consistent collection and we have shown more reliable results than using a swab for collection in longitudinal studies. We’ve also shown higher DNA and RNA amounts, which improves the quality of data we can present to our clients, and to their customers. Industry Challenges & Our Solutions 16S/ITS Sequencing on the microbiome doesn’t resolve species or strain level information Sequential uses shotgun metagenomic sequencing in our R&D, to understand critical species and strains that are influenced by cosmetic products and influence skin health. We have developed highly specific probes to measure the absolute quantity of these species or strains, down to the copy number. This gives us much more confidence that the microbiome is changing, not just at the community diversity level but at the individual species and strain level. A challenge has also been to have a sufficient database to know which strains of micro-organisms are critical for skin health Sequential has leveraged early datasets from our key advisors, Dr Paola de Sessions, Dr Tom Dawson and Dr Niranjan Nagarajan, to start with a strong foundation of a skin microbiome database. Since then, we have worked with 30+ clients to collect over 12,000 skin microbiome samples which give us a solid understanding of skin microbiome and how products and ingredients affect it. Human biological data is highly sensitive and individuals are concerned about data privacy Sequential uses highly secure encrypted AWS servers to store our microbiome data, in order to perform analysis and results. Only two people in Sequential Bio have direct access to this database and it is securely protected from anyone else having access. Finally, the personal details (name, address, contact details) of the individual samples are de-identified so there’s no way of being able to trace who each microbiome sample comes from. Some companies outsource microbiome testing to third parties A challenge here for the end client is that the price is higher, the quality isn’t always ensured, and the data is shared with another group. Sequential develops all our microbiome probes to test species and strains of micro-organisms in-house and therefore owns the entire process. This ensures higher quality service and a lower end cost to the client we work with. If you are interested in carrying out any research with us and testing products, you can reach us at team@sequential.bio. Our Press Releases https://www.personalcareinsights.com/news/microbiome-start-up-sequential-bio-debuts-first-in-vivo-testing-for-personal-care-industry.html https://www.cosmeticsandtoiletries.com/testing/microbiology/news/22105697/sequential-skin-debuts-sequential-bio-testing-solution