- Principal focus on Sponsors, then CRO’s.
- Maintain strong relationships with existing clients, with high levels of delivery to generate repeat business.
- Identify and develop new relationships with Sponsors and CRO’s that we are not currently working with. Undertake Capabilities Presentations and get MSA’s agreed.
- Focus on areas we are already good at and with excellent metrics, whilst developing database and metrics for new areas.
- Concentrate on high value work that is easier to undertake e.g. by reference to patient access, experience, comorbidities, etc.
- Be mindful of developing capacity through expansion of MERCLINCO Sites to cope with workload. Traditionally 8 good studies (high volume, value and achievable), annually seem the right level, so BD has to focus on getting the best ones that fit our business aims. Our reactive workflow has been strong hence less need for an all out proactive approach.
- Provide a strong, value driven proposal through blended rates and a thought out delivery package.
REGULATORY AND FEASIBILITY
Our Feasibility Division is one of the key components of our time-saving Centralised Hub.
- MERCLINCO has a centralised dedicated Feasibility Team.
- Working closely with all our sites.
- Early rapid response from sites makes for optimised feasibility turnaround times to Sponsors/CROs.
- 3 Days for initial list of sites and estimated enrolment (majority will responded within 1 day).
- 5-7 Days for completed site-feasibilities.
- A streamlined centralised feasibility process.
- Proceeding straight to site selection.
- Capabilities slides for each therapeutic area, for each country.
- A Top Down approach – using Sponsor requirements and needs – to finalise feasibilities. This data is then used as a basis for our site-customised recruitment strategies.
South Africa – IEC
- Mixture of 2 x private IEC’s for private sites, academic IEC’s for University sites.
- Submission made monthly on scheduled submission dates, followed by an IEC meeting two weeks later.
- Approvals received between 2-4 weeks following the scheduled meeting (if no
- Once IEC approval is received, client must submit Material Transfer Agreement to the DOH to obtain Export Permit for lab samples (3-4 weeks for approval). During 2018 we have experienced a huge backlog in export permit approvals that resulted in a delay in approvals, but turnaround time has improved since.
BUDGETS AND CONTRACTS
The Budgets & Contracts Division is another one of the key components of our time-saving Centralised Hub.
Turnaround time: 10-20 days for full costing, subject to information provided. Ballpark budgets may be quicker.
We provide a central budget with blended rate in our standard template; Sponsor budgets typically do not include line items for our model & the additional activities undertaken to deliver our premium services.
- Our metrics provide for predictive ability and consistency.
- Affordability (per patient rates) is our Hallmark.
- We have aligned our budget presentation so that it is a familiar format, offering transparency.
- We offer flexibility and can move costs within the budget to meet client needs.
- We have a pragmatic approach to risk share strategies.
Turnaround time: typically 2-4 weeks – subject to sponsor timelines, negotiation of budget and contractual terms.
Our preferred process is one study-specific central contract (within an overarching MSA) covering all sites involved.
- Provides maximum efficiency and facilitates rapid start.
- We approve the contract within 24-48 hours of budget approval.
- Through our advanced processes we are able to decrease contract cycle times.
- Sponsor contract requirements can be accommodated.
- MERCLINCO takes care of all our sites contracting via our own robust contracting structure and processes, thereby saving CRO resource.
- Amendments are easily managed.
- Central invoicing – We pay the Sites and Vendors.
- Metrics set up on a national study basis in line with sponsor expectations.
Our Programme Management Team is currently lead by the Project Manager assisted by a Deputy.
Study Set-up – Centralised at Head Office, for all our sites.
- One point of contact for Programme Management across all MERCLINCO sites.
- Central ‘essential documentation’ collection to expedite start up and reduce admin burden.
- Central EC management to facilitate speedy submissions.
- Central oversight on study level training and follow up.
- Supplies and SIV coordination.
WE HAVE OPERATIONAL PROCESSES IN PLACE THAT ENSURE PRIORITISED START-UP OF OUR SITES.
TRACK RECORD: FPFV within 24 hours of SIV in >90% of studies conducted at MERCLINCO sites.
- Is one of the biggest challenge and source of delay in conducting clinical trials at the desired speed.
- Our success is shown in our ability to deliver above expectations time and again.
- We utilise our tried and tested customised study- and site specific communication strategies to enrol patients from underrepresented groups.
- Diversity-recruitment is our strength and differentiator.
- Continuous lessons learned and mitigation across multiple MERCLINCO sites are implemented in real time.
- Weekly reports to provide oversight of all up front activities.
- Management of conversion rates throughout the recruitment funnel to ensure low fail rates.
- Escalation points are an integral part of our recruitment successes.
- SCRS SPRIA Winners – 2015 & 2019 – recognises our achievements in recruitment – these successes were achieved through our tried and tested approach of customising study-specific and site-specific recruitment – CEO and COO are hands-on when it comes to recruitment.
- Family run business, therefore, personalised attention to detail.
- No two recruitment strategies are the same – even for different studies at the same site
- There is no substitute or an over-arching recruitment model that can be applied across multiple sites and multiple studies.
- RETENTION, RETENTION & RETENTION is just as important as RECRUITMENT.
Maintenance And Close Out
- Manage re consents and protocol amendments.
- Support database lock to ensure deadlines are met.
- Internal audits Focused on inspection readiness – RED FILE
- Study vendor and site level audits.
- Operational Compliance visits performed regularly by Quality Defenders.
- Review of monitoring reports to assess trends FU Letter Training Sessions.
- Management of Quality Issues (QIs) (root cause analysis, CAPA process).
- Supporting client audits/reg inspections.
SOP Management And Mandatory Training Licenses Management
- 75 SOPs issued to date and controlled Docs (Standardisation of processes).
- Training File Management (Centralized GCP, IATA & Anti Bribery training).
- Mandatory training licenses are issued for GCP, IATA, and Anti-Bribery courses (completion ensured within required timescales).
Experienced Teams And Dedicated Data Coordinators Who Work Full Time On Data Entry.
- DCs are trained and experienced in all commonly used eCRF and safety reporting systems.
- Timely data entry and rapid query resolution metrics to monitor data entry.
- Close management of database locks enables timely sponsor data analysis.