Phase II and Phase III studies:
To take a pharma product to the next stage, INVESTIGACION PARTNER SMO LLP experienced to provide a detailed Feasibility Study, Regulatory support, and complete study conduct. We have effectively provided turn-key solutions for unique requirements of the sponsors, which enabled us to work together commendably. INVESTIGACION PARTNER SMO LLP has supported various organizations with their development programs through our full-service solutions.
When establishing safety and efficacy is the primary goal, INVESTIGACION PARTNER SMO LLP has assisted sponsors through monitoring safety, demonstrating effectiveness, and the evaluation of benefit-risk ratio. Our experienced team has efficiently supported clinical trials at any time – at any stage – starting at protocol development through final submission and post-marketing. Thereby we become the preferred partners for many sponsors / CROs.
“INVESTIGACION PARTNER SMO LLP outshone by selecting sites with dedicated, experienced investigators and the appropriate patient population,
Phase IV / Post-Marketing studies:
At this vital phase of clinical research, INVESTIGACION PARTNER SMO LLP has been an experienced strategic partner, and have supported sponsor’s needs and met their research objectives whether monitoring safety, demonstrating effectiveness, evaluating benefit-risk to gain market access, or proving efficacy by providing customized strategic and scientific solutions in a cost-effective and unified approach.
INVESTIGACION PARTNER SMO LLP capability in this vital phase includes:
- Retrospective data collection
- Health outcomes/economics
- Effectiveness comparatives
- Safety outcomes
- Patient-reported outcomes
- Patient registry studies
Rescue Studies:
The complexity of clinical trials and the pressures of meeting deadlines can lead to the need for supplemental or replacement assistance. INVESTIGACION PARTNER SMO LLP was able to seamlessly work alongside other CROs using its established processes to ensure Investigacion Partner SMO LLP both integration with sponsors and/or other vendors. Our corporate structure promotes flexibility, and our working practices can be far more efficient and effective than larger organizations. Our sites network and centralized operations model allowed INVESTIGACION PARTNER SMO LLP to quickly initiate sites. Your need for additional sites in an active study, sites in new study or want to allocate an ongoing study, INVESTIGACION PARTNER SMO LLP can accomplish your enrollment targets while bringing quality data. Our team will quickly analyze the options for enrollment. After assessment, the project plan is initiated and a parallel team works towards achieving the regulatory approval, site agreements and logistical requirements for the study.
Biosimilars Studies
Interest in Biosimilar drug development has increased dramatically particularly driven by the promise of reductions in the cost of treatments, particularly with recent biosimilar drug approvals by the international and Indian regulatory agencies. To move a program forward successfully, several critical questions have to be answered including: a complete analysis of biosimilarity (how similar is “similar”), extrapolation, and immunogenicity. INVESTIGACION PARTNER SMO LLP offers a complete solution for the clinical trial conduct of Biosimilars, and expertly manage the operational aspects of these trials.
Ayurvedic / Herbal products Studies:
INVESTIGACION PARTNER SMO LLP has experience in conducting ayurvedic / herbal consumer products clinical trials and meeting the objective of the study within the targeted timelines, subjects’ recruitment and retention and timely completion of the clinical study.
