We are specialized in the planning, management, execution and analysis of Phase I-IV clinical trials.
We successfully deliver trial management solution, identifying key leadership roles with global project management experience.
We provide a flexible and dedicated workforce, seamlessly integrated into our client's team to execute the trial management.
In today's dynamic environment, the complexity of clinical trial project poses significant challenges for the sponsor aiming to achieve timely completion, budget adherence, and high-quality data.
As access to patients continue to be a task for the industry, we can leverage through our network operated sites and trusted site alliances into a bigger patient population.
Our team of specialists who conduct an extensive site selection process before inclusion of site in our network.
Our Identification, Enrolment & Engagement program, galvanizes the investigator site & patients to actively participate in a trial.
Determining eligibility of Investigator and the site through exhaustive verification checklist to comply regulatory requirements.
We conduct background checks of potential sites, such as audit history, debarments, 483 issues etc.
A network of investigator sites across pan India. Investigators spanning a wide spectrum of therapeutic areas.
Investigators having experience in global trials.
Our professionals apply their therapeutic, regulatory and operational expertise to consistently solve the predicaments that arise during clinical project. Our experienced project manager serves as single point contact for the study sponsor. From start-up to close-out, performance is monitored and measured against contractual timeline and agreed budget.
Knowledge based selection.
Involvement from strategic planning to close out.
Lead team through every step.
Study start up using streamlined processes.
Proficient in patient recruitment, retention and engagement.
Oversight of third-party vendors.
Harmonization with all stake holders.
The recent surge in the availability of natural/herbal supplements & nutraceuticals is largely driven by their health benefits and natural origin.
We lend support to aid you carve a niche in the nutraceuticals product development process allowing growth in market size and facilitate product differentiation.
Our team of experts will help you understand requirements and provide solutions in accordance with regulatory guidelines.
We extend our end to end services from product plan development to submission and even post submission query responses.
• To meet the challenges of marketplace, changing trends and ever-demanding consumer needs, high quality, effective evaluation of cosmetic and personal care products is essential.
• Clinical testing of cosmetics and personal care products ensure product is safe and effective for consumer use.
• We have expertise in safety and efficacy studies in cosmetology and trichology for creams, lotions, hair care products, deodorants, chemical peels, beauty products and devices etc.
• We also conduct clinical studies in dermatology for dermatitis, psoriasis, acne, skin allergies, rashes, baby products etc.
• We facilitate clinical trial in anti-aging and other claim-substantiating studies for skin and hair care products.
• Biomic understands the unique requirements of medical devices and diagnostics. Our team is well-versed with the global regulatory and clinical trial requirements for a full range of medical devices and diagnostic products.
• Biomic by its scientific expertise and capabilities can help clients in developing clinical strategy for ANDA, NDA & 505(b)2 products.
• Through our proficiency we can help sponsor in every aspect of clinical pharmacology including BA/BE studies, PK in healthy subjects/patients and pharmacodynamic studies.
• We provide comprehensive solutions for the bioanalysis of small molecules, biomarkers and biologics.
• We can help sponsor, design, execute, interpret and report clinical pharmacology studies.
• Through our industry experienced monitors and auditors we can manoeuvre a monitoring plan for BA/BE & PK studies.
• We help our clients identify right facility with scientific insight for the execution of preclinical & toxicity studies in compliance with the GLP requirements.
• Our dedication to advancing preclinical research goes beyond innovative animal studies.
• Our experienced scientists determine the safety and efficacy of compounds, ensuring that testing is controlled, reliable and quality data is generated.
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